MAUDE Adverse Event Report: PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM

Catalog Number AB2000

Device Problems Mechanical Problem (1384); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation by manufacturer: the aquabeam handpiece was returned along with the scope carriage for investigation.Visual inspection confirmed that the handpiece was bent, and the scope carriage separated from the axle, hence reported failures were confirmed.A review of the device history record (dhr) ab2000-b / serial number (b)(4) and aquabeam handpiece / lot number (b)(4) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.A review of the aquabeam robotic system instructions for use, ifu0105-00 rev.A.States the following: 5.Precautions.5.1.Precautions: general.If excessive resistance is encountered during aquabeam scope positioning, reposition the aquabeam handpiece to minimize tenting the prostate in order to reduce the chance of damaging the aquabeam scope.It is possible that an atypical patient anatomy may have caused the handpiece to be bent and the excessive force on the scope carriage might have separated the scope carriage body from the axle.However, the cause cannot be confirmed.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procep) became aware that during the aquablation procedure the aquabeam handpiece bent, and the scope carriage cracked.As a result, the handpiece was replaced with a new handpiece unit and the procedure was continued through successful completion.The reported event caused a surgical procedural delay of over 20 minutes.There were no adverse health consequences to the patient due to the procedural delay.

• Brand Name: AQUABEAM ROBOTIC SYSTEM
• Type of Device: FLUID JET REMOVAL SYSTEM
• Manufacturer (Section D): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer (Section G): PROCEPT BIOROBOTICS CORPORATION; 900 island drive; suite 101; redwood city CA 94065 1494
• Manufacturer Contact: doria esquivel ; 900 island drive; suite 101; redwood city, CA 94065-1494
• MDR Report Key: 16080962
• MDR Text Key: 308452052
• Report Number: 3012977056-2022-00180
• Device Sequence Number: 1
• Product Code: PZP
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male