• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PROCEPT BIOROBOTICS CORPORATION AQUABEAM HANDPIECE; FLUID JET REMOVAL SYSTEM Back to Search Results
Model Number HP2000
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2023
Event Type  malfunction  
Event Description
Hand piece failed to prime.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
AQUABEAM HANDPIECE
Type of Device
FLUID JET REMOVAL SYSTEM
Manufacturer (Section D)
PROCEPT BIOROBOTICS CORPORATION
150 baytech drive
san jose CA 95134
MDR Report Key19125652
MDR Text Key340390725
Report Number19125652
Device Sequence Number1
Product Code PZP
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberHP2000
Device Catalogue NumberHP2000
Device Lot Number23C01671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/16/2023
Event Location Hospital
Date Report to Manufacturer04/17/2024
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/17/2024
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age82 YR
Patient SexMale
-
-