PROCEPT BIOROBOTICS CORPORATION recalls AQUABEAM Handpiece, REF: HP2000, a sterile single-use compon
Recalled Product
AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.
Hazard / Issue
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.
Issued by
FDA
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