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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 Problem Pulmonary Embolism (1498)
Event Date 05/02/2023
Event Type  Injury  
Event Description
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation (procept) was made aware that the patient developed a pulmonary embolism (pe) post aquablation procedure but prior to the initiation of hemostasis.Once the patient's vital signs were stabilized, the surgeon utilized a turp loop to complete hemostasis.The patient was intubated and taken to the intensive care unit.The pe was reported to have no association with the aquabeam robotic system.The patient was later reported to have been extubated and alert.No malfunction of the aquabeam robotic system was reported during the aquablation procedure.
 
Manufacturer Narrative
Root cause of 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.
 
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 device history record (dhr), and labeling.A review of the device history record (dhr) 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 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: o embolism a root cause for the reported event could not be determined.It was reported that once the patient's vitals were stabilized, a turp loop was used to finish hemostasis.The treating physician do not suspect that the issue is related to the device and that anesthesiologist stated that the patient likely came in with the clot.The aquabeam robotic system instructions for use embolism as a potential risk of the aquablation procedure.No further information was able to be obtained on this event.Based on the event details plus a 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
900 island drive
suite 101
redwood city CA 94065
Manufacturer (Section G)
PROCEPT BIOROBOTICS CORPORATION
900 island drive
suite 101
redwood city CA 94065
Manufacturer Contact
doria esquivel
900 island drive
suite 101
redwood city, CA 94065
6502327291
MDR Report Key16939118
MDR Text Key315297730
Report Number3012977056-2023-00077
Device Sequence Number1
Product Code PZP
UDI-Device IdentifierB614AB20001
UDI-Public+B614AB20001/16D20230206D
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 Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 07/12/2023
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 Model NumberAB2000
Device Catalogue NumberAB2000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/02/2023
Initial Date FDA Received05/16/2023
Supplement Dates Manufacturer Received06/29/2023
Supplement Dates FDA Received07/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/06/2023
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) Hospitalization; Required Intervention;
Patient SexMale
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