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

Model Number AB2000

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 10/04/2022

Event Type  malfunction  

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 and aquabeam scope were bent when attempting to reach over the median lobe.The same scope was used in a second handpiece, which also bent during insertion, causing the scope to break.A new handpiece and new scope were used to complete the procedure successfully.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.

Manufacturer Narrative

Manufacturer narrative: investigation is currently in-process.No root cause has yet been determined.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.No issues were found with the console.How the errors occurred remains undeterminable as no problems were detected during testing.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam handpiece was not returned for investigation as it was confirmed to have been discarded by the user.A review of the device history record (dhr) ab2000-b / serial number (b)(6) / lot number 22c01212 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 and associated component met all design and manufacturing specifications when released for distribution.The aquabeam robotic system user manual, um0101-00 rev.F, was reviewed and states the following: 11.2.5 sterile: aquabeam handpiece and aquabeam scope setup states: -hold the distal end of the scope tube tip approximately 1 inch (2.54cm) from the fully proximal position and continue advancing the aquabeam scope forward until it is properly engaged with the aquabeam handpiece and then rotate the proximal key alignment adapter so that the dimple on the proximal key alignment adapter is facing up.-an audible click should be heard when the aquabeam scope is securely engaged with the aquabeam handpiece.Note: do not use excessive force to advance the aquabeam scope.If resistance is felt, gently rotate the aquabeam scope clockwise and counterclockwise while simultaneously applying forward pressure.The aquabeam robotic system user manual, ifu0101-00 rev.E, states the following: 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.Per the information received, the bending of the stainless-steel components of the handpiece was likely due to the handling of the handpiece by the physician mentioned in the event reporting.Thus, the root cause was determined to be use error as the user applied excessive force causing the handpiece to bend.The user manual explicitly mentions repositioning the handpiece if resistance is encountered.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• 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: 15727834
• MDR Text Key: 307196677
• Report Number: 3012977056-2022-00149
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D20190315L
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 11/15/2022

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 Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/04/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 11/10/2022
• Supplement Dates FDA Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male