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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
Catalog Number AB2000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Dysuria (2684)
Event Date 06/26/2023
Event Type  Injury  
Manufacturer Narrative
Root cause of the reported event has not yet been established.Investigation by manufacturer is currently in process.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 (procept) became aware that post-aquablation treatment, the patient experienced dysuria which was treated with medication.The treating surgeon confirmed that the aquabeam robotic system functioned as intended, and assessed the event to be related to the procedure.No malfunction of the aquabeam robotic system was reported.
 
Manufacturer Narrative
The aquabeam robotic system is a reusable device; therefore it is currently in the possession of the user facility.The investigation of this event consisted of a review of the device history record (dhr) and labeling.A review of the device history record (dhr) ab2000-c/serial number (b)(6) was conducted, which confirmed that there were no non-conformances, failures, discrepancies, or missed steps during the manufacturing process that could be related to the reported event.The review indicated that the system met all design and manufacturing specifications when released for distribution.The aquabeam robotic system instructions for use (ifu), ifu0101-00, rev.E, was reviewed and states the following: 4.3.Warnings: procedure as with any surgical urologic procedure, potential perioperative risks of the aquablation procedure include: - dysuria.The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The treating surgeon confirmed that the aquabeam robotic system functioned as intended, and assessed the event to be related to the procedure.The aquabeam robotic system's ifu lists dysuria as a potential risk of the aquablation procedure.Based on the review of the 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.
 
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Brand Name
AQUABEAM ROBOTIC SYSTEM
Type of Device
FLUID JET REMOVAL SYSTEM
Manufacturer (Section D)
PROCEPT BIOROBOTICS CORPORATION
150 baytech drive
san jose CA 95134
Manufacturer (Section G)
PROCEPT BIOROBOTICS CORPORATION
150 baytech drive
san jose CA 95134
Manufacturer Contact
doria esquivel
150 baytech drive
san jose, CA 95134
MDR Report Key17951927
MDR Text Key325900481
Report Number3012977056-2023-00171
Device Sequence Number1
Product Code PZP
UDI-Device IdentifierB614AB2000C1
UDI-Public+B614AB2000C1/16D20220330O
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
DEN170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 11/20/2023
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 NumberAB2000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/21/2023
Initial Date FDA Received10/17/2023
Supplement Dates Manufacturer Received11/16/2023
Supplement Dates FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/30/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
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