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

Model Number AB2000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

The product is unavailable for investigation as it is currently in use at the user facility.Investigation by manufacturer is currently in-process.

Event Description

A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that during the aquablation procedure the presence of bladder stones not previously identified were found.The treating physician inserted a stone crushing forceps (a non-procept device) to remove the bladder stones from under the median lobe and a bladder perforation occurred.The physician injected dye under fluoroscopy to examine the extent of the bladder perforation, which was confirmed to be localized.A foley balloon catheter was left in place to allow for healing of the perforation.The aquablation procedure was aborted due to the patient's condition described herein.No malfunction of the aquabeam robotic system occurred during this event.

Manufacturer Narrative

H3.Device evaluation by manufacturer: the aquabeam robotic system was not returned for investigation as it is currently in use at the user facility.A review of the aquabeam robotic system's log file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review indicated that the system functioned as designed.A review of the device history record (dhr) for ab2000-b/serial number (b)(6) 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 device met all design and manufacturing specifications when released for distribution.A review for similar complaints under ab2000-b/18c00764 confirmed no other similar events.A review of similar complaints across all other systems confirmed found no similar events.The aquabeam robotic system instructions for use, ifu0101-00 rev.E, states: 3.Contraindications.Do not use the aquabeam robotic system in patients who do not meet the indication for the system's intended use.The aquabeam robotic system was not returned for investigation of this complaint.A review of the log file confirmed that the system was primed successfully, and no errors were observed.There was no aquablation performed, and the system did not progress past the aquabeam handpiece setup step.The reported bladder perforation occurred during a non-aquablation procedure with a non-procept device.Based on the information received, plus the review of the log file, dhr and ifu, the event is considered not to be device related.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
• MDR Report Key: 11041910
• MDR Text Key: 222626253
• Report Number: 3012977056-2020-00085
• Device Sequence Number: 1
• Product Code: PZP
• UDI-Device Identifier: B614AB20001
• UDI-Public: B614AB20001
• Combination Product (y/n): N
• PMA/PMN Number: DEN170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AB2000
• Device Catalogue Number: AB2000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 05/13/2021
• Supplement Dates FDA Received: 05/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention