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

Model Number AB2000

Device Problems Break (1069); Mechanical Jam (2983); Patient Device Interaction Problem (4001)

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

Event Date 11/09/2021

Event Type  malfunction  

Manufacturer Narrative

Root cause of reported event has not yet been established.Investigation by manufacturer is currently in process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).The patient had previously undergone prostatic urethral lift procedure.Procept biorobotics corporation became aware that during the aquablation procedure, due to the urethral clips in the patient, the aquabeam scope tubing was bent during insertion of the aquabeam handpiece.The treating physician was unable to get the aquabeam handpiece over the median lobe into the bladder due to the patient's anatomy, causing both the handpiece and scope to break.The treating physician decided to abort the aquablation procedure and converted to a transurethral resection of the prostate (turp) surgical procedure.There were no adverse health consequences to the patient due to the reported event.

Manufacturer Narrative

H.10 additional manufacturer narrative: the aquabeam handpiece and associated aquabeam scope were returned for investigation.Visual inspection confirmed the scope was stuck inside the handpiece.Damage to the proximal tip of the scope was observed after removal from the handpiece.The handpiece was found to be slightly bent and the telescoping tube was stuck.Additional analysis found cracks in the manifold glue and galling on the scope tube which indicate excessive force was applied on the handpiece and with the added compression force applied when translating the scope.A review of the device history record (dhr) for ab2000/serial number (b)(6) and associated handpiece/lot number 21c00527r1 was performed, which confirmed that there were no nonconformances, 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.No other simiar events have been reported to procept.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: while supporting the aquabeam handpiece, gently grip the middle of the semi-rigid section of the aquabeam scope and partially insert through the clear rubber seal on the bottom of the aquabeam handpiece.Hold the distal end of the scope tube tip approximately 1 inch (2.54 cm) 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.Confirm the aquabeam scope is fully engaged by advancing and retracting the scope proximal key and observing the scope tube tip moving in concert with the aquabeam scope.The aquabeam robotic system instructions for use, ifu0101-00 rev.E, 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.The probable root cause for the reported failure mode is due to a bent telescoping tube from compressive load applied from insertion of the handpiece during the procedure as evidenced by cracks on the manifold glue and galling.The user manual and instructions for use contain troubleshooting instructions for the user to follow to avoid damaging the handpiece.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: 12973090
• MDR Text Key: 285550230
• Report Number: 3012977056-2021-00098
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: +B614AB20001/16D202010016
• 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: 01/26/2022

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/09/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 01/25/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2020
• 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