Transducer, an ultrasound system accessory, consists of two parts that are bonded together that may come apart due to chassis bonding issue, which may pose risk to users and patients of tissue damage, and electric shock if the built-in safety measures to prevent electric were to also fail.
Jun 30, 2023 Other Medical Devices Nationwide
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The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002
Jul 27, 2023 Other Medical Devices Nationwide
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Philips Medical Systems Nederland B.V.
Class I - Dangerous
A foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation
Jul 19, 2023 Other Medical Devices Nationwide
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Sterility of device may be compromised due to breach of the chevron seal of the packaging
Jul 24, 2023 Other Medical Devices Nationwide
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Trocar manufactured with the shaft too long and does not meet manufacturing specifications. As a result, when used with the 30¿ neuroendoscope, a portion of the visual field is obscured.
Jul 20, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Their is a potential that optical devices with insufficient anti-reflective coating may lead to incorrect axial length measurements.
Aug 8, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
IFU labeling is being updated to revise EtO gas mixture and elimination of reusable cleaning brushes.
Jul 20, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Complaint of endoscope model becoming lodged in the endotracheal tube connector due to diameter being too large.
Jul 27, 2023 Other Medical Devices Nationwide
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Olympus Corporation of the Americas
Class I - Dangerous
Recent reports of patient infection.
Jul 27, 2023 Other Medical Devices Nationwide
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Awl instrument adjustable drill button assembly assembled in the incorrect orientation, preventing locking feature from engaging with shaft at the desired set point; instruments lack ability to control awl depth by means of adjustable shaft advancement stop, which may lead to over insertion, dural tear, vascular/neurologic injury, adjacent tissue damage, increased operative time, revision surgery.
Jul 7, 2023 Other Medical Devices Nationwide
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