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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 Sexual Dysfunction (4510)
Event Date 10/14/2023
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 ejaculatory dysfunction.No malfunction of the aquabeam robotic system was reported.
 
Manufacturer Narrative
The aquabeam robotic system is a reusable device; therefore, it is still currently in possession of the user facility.The investigation of this event consisted of a review of the treatment log files, device history record (dhr), and labeling.The aquabeam robotic system's treatment logs file was reviewed, which confirmed no malfunctions during the aquablation procedure.The review of the treatment logs indicated that the system functioned as designed.A review of the device history record (dhr) for ab2000-b/ 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 device 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: sexual dysfunction, including ejaculatory and erectile dysfunction.A root cause for the reported event could not be determined.The aquabeam robotic system instructions for use list ejaculatory dysfunction as a potential risk of the aquablation procedure.Based on the event details plus a review of the dhr, treatment log files, 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 Key18083588
MDR Text Key327515397
Report Number3012977056-2023-00203
Device Sequence Number1
Product Code PZP
UDI-Device IdentifierB614AB20001
UDI-Public+B614AB20001/16D20211015C
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
DEN170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/01/2024
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 10/26/2023
Initial Date FDA Received11/07/2023
Supplement Dates Manufacturer Received02/12/2024
Supplement Dates FDA Received03/01/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/15/2021
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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