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PROCEPT BIOROBOTICS

2 recalls •
🏥 Medical Devices
• Categories: Other Medical Devices

AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.

Class I - Dangerous

Scope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both tip detachment and entire tip separation form the handpiece may lead to procedural delay for handpiece exchange. Tip detachment can be seen cystoscopically and tip separation from the handpiece may necessitate tip removal from the bladder or prostate.

Jul 9, 2021 Other Medical Devices Nationwide View Details →

AquaBeam Handpiece, Sterile EO, Rx Only, REF: 310301, and 320301, a component of AquaBeam Robotic System. 320301 distributed outside the U.S. Device Description The AQUABEAM Robotic System is intended for use in patients suffering from lower urinary tract symptoms resulting from benign prostatic hyperplasia (BPH).

Class I - Dangerous

Certain lots may develop an internal leak due to a micro-crack in a specific weld joint within the device. When the Robot detects this failure, it immediately renders the device inoperable and notifies the user via an error message, which may cause delay and/or inability to complete the procedure.

Mar 6, 2019 Other Medical Devices Nationwide View Details →