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

Catalog Number 210101

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/31/2019

Event Type  Injury  

Event Description

Male underwent aquablation procedure.It was reported that prior to the aquablation procedure, the patient had undergone a laser bladder stone procedure and had been bleeding for a week post-procedurally.Prior to the aquablation procedure, a cystoscopy was performed to assess the patient and several clots were removed.The physician noted that the patient began to bleed during the cystoscopy assessment.There was bleeding observed during the aquabeam handpiece insertion as well.Post-aquablation procedure, clot evacuation was performed along with light unipolar cauterization (with loop) at the bladder neck.Per standard post-operative procedure, the patient was catheterized with a foley balloon catheter inflated at 60 cc with light bladder neck traction, which achieved good color in catheter.The catheter was then flushed without continuous bladder irrigation (cbi) and patient was taken into the post-anesthesia care unit (pacu).Approximately an hour later, the pacu staff attempted to flush the catheter and start cbi, but the catheter was blocked due to clots and had to be replaced.A new catheter was inserted, inflated to 60 cc, and cbi was started about 105 minutes post-aquablation procedure.The patient became hypotensive and was administered medication.The physician reported that the patient's hemoglobin (hgb) level dropped from 12.1 g/dl pre-procedure to 8.1 g/dl in the pacu, therefore the patient received two (2) units of blood transfusion.Per manufacturer's instructions for use, bleeding is a potential risk after aquablation procedure.No other clinical sequela was reported with the patient.No malfunction of the aquabeam robotic system was reported.

Manufacturer Narrative

The aquabeam system's log file was reviewed, which confirmed no malfunctions related to the reported event.The review of the log file indicated that the system functioned as designed.A review of the device history record (dhr) for lot number 18c00487 was conducted, which confirmed that there were no nonconformances generated during the manufacturing process of this system.The review indicated that the system met all required specifications when released for distribution.A review for similar complaints was performed on the aquabeam system's, lot number 18c00487, which confirmed that there was one (1) other similar event reported on this lot.The aquabeam robotic system's instructions for use (ifu), ifu310301, rev.F, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.The system was not returned for investigation of this complaint.Bleeding is a potential risk of the aquablation procedure.Based on the review of the log file, dhr, and ifu, the event is considered not to be device related.Corrected data: for corrected data, please refer to the following: suspect medical devce, catalog #, lot #, udi #.Initial reporter, name and address, device manufacturer date.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: 9378292
• MDR Text Key: 168443389
• Report Number: 3012977056-2019-00061
• 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: 12/16/2019

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 Catalogue Number: 210101
• Device Lot Number: 18C00487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/26/2019
• Supplement Dates Manufacturer Received: 12/12/2019
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention