MAUDE Adverse Event Report: PROCEPT BIOROBOTICS AQUABEAM SYSTEM; FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL

Model Number	NONE
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of available imaging suggested that rectal perforation was most likely caused by the transrectal ultrasound (trus) probe ((b)(4) model #8848).Perforation was not caused by the waterjet or the transurethral aquabeam handpiece.
Event or Problem Description
A man underwent aquablation for symptomatic benign prostatic hyperplasia.Patient had history of rectal polyps and diverticulitis.Two days after an uneventful aquablation procedure he developed abdominal pain with peritoneal signs.Abdominal ct showed free air in the abdomen.He underwent laparotomy during which a 1 cm rectal perforation in the anterior rectum 2 cm beyond the prostate was observed.
Additional Manufacturer Narrative
Subsequent investigation into this event concluded that the rectal perforation was likely caused by the physician exerting excessive upward pressure of the trus probe on the anterior rectum.This was confirmed by ultrasound images that showed the prostate being wrapped around the probe.The posterior-most aspect of the prostate could not be seen, consistent with excessive force being applied.The aquabeam system's instructions for use (ifu), ifu320301, rev.D, lists rectal perforation as a potential perioperative risk of the aquablation procedure.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.

• Brand Name: AQUABEAM SYSTEM
• Common Device Name: FLUID JET SYSTEM FOR PROSTATE TISSUE REMOVAL
• Manufacturer (Section D): PROCEPT BIOROBOTICS; 900 island drive, suite 210; redwood city CA 94065
• MDR Report Key: 7481214
• Report Number: 3012977056-2018-00001
• Device Sequence Number: 16498056
• Product Code: PZP
• UDI-Device Identifier: B6142101011
• UDI-Public: B6142101011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: DEN170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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
• Operator of Device: Physician
• Device Model Number: NONE
• Device Catalogue Number: 220101
• Device Lot Number: 16C0055-01
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/07/2018
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/02/2018
• Supplement Report FDA Received Date: 01/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BK MEDICAL TRANSRECTAL ULTRASOUND; BK MEDICAL TRANSRECTAL ULTRASOUND
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention