Other Medical Devices

It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

Communications between the Patient Positioning System and the accuracy filter can periodically fail with no clear indication to the operator.

Blast Bandages (part# BLAST) with Lot# 0617 were not terminally sterilized.

It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subsequently mold may grow in the pooled, leaked media.

Leaks complaints.

Upon completion of a 6D workflow, the HexaPOD evo Module may be in a tilted state if it is moved to the position used for 3D (non-iGUIDE) treatments resulting in incorrect patient positioning.

One lot, the wire harness was over-crimped on some of the connectors that go to the two vertical side switches on the exam table.

The suction valve may not close properly which could cause continuous suction.

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

The suction valve may not close properly which could cause continuous suction.

The suction valve may not close properly which could cause continuous suction.

The suction valve may not close properly which could cause continuous suction.

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

Device may be missing a sled component. The sled component is responsible for staple deployment. This may result in failure to form a staple line when tissue is divided, leading to bleeding or leakage of luminal contents.

The suction valve may not close properly which could cause continuous suction.

The suction valve may not close properly which could cause continuous suction.

The needle associated with certain suture product codes has the potential to perforate the packaging due to a packaging design issue. A perforated package has the potential to cause a soft tissue injury to a healthcare professional handling the subject product or a patient infection due to a breach of sterility within the packaging if it goes unnoticed by the healthcare professional.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.

Use of the impacted product may cause a superficial infection requiring PO antibiotics and wound care or deep infection requiring IV antibiotics and device removal.