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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 Hemorrhage/Bleeding (1888)
Event Date 09/22/2020
Event Type  Injury  
Manufacturer Narrative
A review of the device history record (dhr) serial number (b)(4) 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 upon release for distribution.A review for similar complaints was performed on serial number (b)(4), which confirmed no other similar events have been reported on this system.A review of similar events on all other systems confirmed 4 other similar events.The aquabeam robotic system's instructions for use (ifu), ifu0104-00, rev.D, was reviewed and bleeding is listed as a potential perioperative risk of the aquablation procedure.As the product was not returned for investigation, 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 information received by the treating physician, a review of the dhr and ifu, the event is considered not to be device related.
 
Event Description
A male patient underwent an aquablation procedure for symptomatic benign prostatic hyperplasia (bph).Procept biorobotics corporation became aware that post-aquablation procedure the patient received a blood transfusion (number of units unknown) due to a decrease in hemoglobin levels (per manufacturer's instructions for use, bleeding is a potential perioperative risk of the aquablation procedure).The treating physician confirmed that the blood transfusion was not attributed to the aquablation procedure, but rather to the patient's pre-operative condition.The patient was reported to be in good condition.No further information was provided.
 
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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
Manufacturer (Section G)
PROCEPT BIOROBOTICS CORPORATION
900 island drive
suite 101
redwood city CA 94065 1494
Manufacturer Contact
doria esquivel
900 island drive
suite 170
redwood city, CA 94065-1494
6502327291
MDR Report Key10805688
MDR Text Key216663418
Report Number3012977056-2020-00061
Device Sequence Number1
Product Code PZP
UDI-Device IdentifierB614AB20001
UDI-PublicB614AB20001
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
DEN170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/06/2020
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 10/07/2020
Initial Date FDA Received11/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2019
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) Required Intervention;
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