Recall Z-2330-2021— PROCEPT BIOROBOTICS CORPORATION

Name: FDA recall Z-2330-2021
Creator: U.S. Food and Drug Administration
Published: 2021-07-09

Class II · Ongoing

Class II FDA medical device recall by PROCEPT BIOROBOTICS CORPORATION, initiated 2021-07-09. It names one FDA 510(k) clearance: K202961. Product: AQUABEAM Handpiece, REF: HP2000, a sterile single-use component of the AQUABEAM Robotic System.. Reason: 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..

Recalling firm: PROCEPT BIOROBOTICS CORPORATION
Classification: Class II
Status: Ongoing
Initiated: 2021-07-09
Firm location: Redwood City, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K202961 — AquaBeam Robotic SystemProcept Biorobotics, Corporation·cleared 2021-03-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.