BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 17757529 · Received September 15, 2023

    Report

    Report Number
    2955842-2023-18455
    Event Type
    Malfunction
    Date Received
    September 15, 2023
    Date of Event
    August 24, 2023
    Report Date
    August 24, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119792
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE MARYLAND BIPOLAR FORCEPS INSTRUMENT WAS ANALYZED AND FAILURE ANALYSIS INVESTIGATIONS REPLICATED/ CONFIRMED THE CUSTOMER REPORTED COMPLAINT. FAILURE ANALYSIS FOUND THE PRIMARY FAILURE OF THERMAL DAMAGE BETWEEN THE GRIPS TO BE RELATED TO THE CUSTOMER REPORTED COMPLAINT. THE INSTRUMENT WAS FOUND TO HAVE CHARRING AND LOCALIZED MELTING AT THE GRIP BASE BETWEEN THE GRIPS. THE INSTRUMENT PASSED THE ELECTRICAL CONTINUITY TEST. ADDITIONAL OBSERVATION(S) NOT REPORTED BY SITE WERE ALSO IDENTIFIED: THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE INPUT DISK CRACKED. INPUT DISK #6 AND #7 WAS FOUND CRACKED INSIDE THE HOUSING. THE INSTRUMENT WAS FOUND TO HAVE AN EXCESSIVE AMOUNT OF DRIED RESIDUE AROUND THE CLAMPING PULLEY CABLE GROOVES. REVIEW OF THE PROVIDED IMAGE IS CONSISTENT WITH THE ALLEGED COMPLAINT OF THE MARYLAND BIPOLAR FORCEPS INSTRUMENT ARCING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LIVER WEDGE RESECTION SURGICAL PROCEDURE, THE SURGEON HAD TO REPLACE THE MARYLAND BIPOLAR FORCEPS INSTRUMENT THREE TIMES AND THERE WAS A PROCEDURE DELAY DUE TO EXCHANGING THE INSTRUMENTS. TWO MARYLAND BIPOLAR FORCEPS INSTRUMENTS ARCED TWICE. THE FIRST INSTRUMENT HAD BLACK MARKS ON THE INSULATION PIECE. THE SECOND INSTRUMENT WAS ARCING AND ALSO HAD BLACK MARKS. THE THIRD INSTRUMENT WORKED FINE. THE PROCEDURE WAS COMPLETED WITH A BACKUP INSTRUMENT. THERE WERE NO REPORTS OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE A FOLLOW-UP ATTEMPT TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294711 ENDOWRIST MARYLAND BIPOLAR FORCEPS NAY INTUITIVE SURGICAL, INC 471172-17 K10230226 0477 00886874119792

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown DA VINCI INSTRUMENTS AND ACCESSORIES