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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC. ENDOWRIST FENESTRATED BIPOLAR FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT

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INTUITIVE SURGICAL, INC. ENDOWRIST FENESTRATED BIPOLAR FORCEPS SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT Back to Search Results
Model Number 471205
Device Problems Use of Device Problem (1670); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 11/23/2021
Event Type  malfunction  
Event Description
During the surgical procedure, attempts were made by the provider to burn uterine tissue with the fenestrated bipolar forcep. The energy level was increased to 5, but the forcep still would not burn the tissue and it was replaced. No harm to patient.
 
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Brand NameENDOWRIST FENESTRATED BIPOLAR FORCEPS
Type of DeviceSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
Manufacturer (Section D)
INTUITIVE SURGICAL, INC.
1266 kifer road
sunnyvale CA 94086
MDR Report Key12951569
MDR Text Key281846707
Report Number12951569
Device Sequence Number1
Product Code NAY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/29/2021,11/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number471205
Device Lot NumberK112108240195
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/29/2021
Event Location Hospital
Date Report to Manufacturer12/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

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