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U.S. Department of Health and Human Services

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

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PROCEPT BIOROBOTICS CORPORATION AQUABEAM ROBOTIC SYSTEM; FLUID JET REMOVAL SYSTEM Back to Search Results
Model Number AB2000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Urinary Retention (2119)
Event Date 09/08/2020
Event Type  Injury  
Manufacturer Narrative
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 post-procedure the patient was taken back to the operating room due to urinary retention, which was addressed by performing cauterization (per manufacturer's instructions for use, urinary retention is a potential perioperative risk of the aquablation procedure).No adverse health consequences were reported with the patient due to this event.No malfunction of the aquabeam robotic system was reported.
 
Manufacturer Narrative
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 serial number (b)(6) was conducted, which confirmed that therere one (1) nonconformance generated during the manufacturing process of this system.The review indicated that the nonconformance was unrelated to the reported event.The system met all required specifications upon release for distribution.A review for similar complaints was performed on serial number (b)(6), which confirmed that there were no other similar events reported on this system.There are four (4) similar events that have been reported across all other systems.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.D, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.O urinary retention.A root cause for the reported event could not be determined.Urinary retention are potential risks of the aquablation procedure.Based on 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.
 
Manufacturer Narrative
H.11 corrected data: 1) b5.Describe event or problem - please refer to updated description of event.2) h.6 event problem evalucation codes.The correct health effect - clinical code is "1888 - hemorrhage/bleeding" 3) h.10 additional manufacturer narrative: the aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.D, was reviewed and states the following: 4.3.Warnings: procedure.As with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: o bleeding.A root cause for the reported event could not be determined.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.Submission of this report does not constitute an admission that the manufacturer's product caused or contributed to the event.
 
Event Description
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-procedure the patient was taken back to the operating room due to clot retention, which was addressed by performing cauterization (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).No adverse health consequences were reported with the patient due to this event.No malfunction of the aquabeam robotic system was reported.
 
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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 Key10709005
MDR Text Key212261038
Report Number3012977056-2020-00053
Device Sequence Number1
Product Code PZP
UDI-Device IdentifierB614AB20001
UDI-PublicB614AB20001
Combination Product (y/n)N
PMA/PMN Number
DEN170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 05/21/2021
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 NumberAB2000
Device Catalogue NumberAB2000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/22/2020
Initial Date FDA Received10/20/2020
Supplement Dates Manufacturer Received12/29/2020
05/21/2021
Supplement Dates FDA Received12/29/2020
05/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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