BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 16656718 · Received March 31, 2023

    Report

    Report Number
    2955842-2023-11664
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    March 3, 2023
    Report Date
    March 6, 2023
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874119785
    PMA / PMN Number
    K214095
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CLAIM AGAINST THE PRODUCT BY THE CUSTOMER NOTING A FRAYED CABLE GOT CAUGHT ON A PATIENT'S TISSUE, AN INVESTIGATION WAS COMPLETED TO DETERMINE THE CAUSE OF THIS REPORTED EVENT. INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE A DA VINCI PRODUCT TO PERFORM FAILURE ANALYSIS. THE PROGRASP FORCEPS INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A FRAYED GRIP CABLE AT THE DISTAL END. THE COMPLAINT REGARDING FRAYED CABLE WAS CONFIRMED BY FAILURE ANALYSIS, WHICH INDICATES THAT THE DEVICE DID CONTRIBUTE TO THE CUSTOMER REPORTED ISSUE. FAILURE ANALYSIS ALSO FOUND ADDITIONAL OBSERVATIONS NOT REPORTED BY THE CUSTOMER AND NOT RELATED TO THE REPORTED ISSUE: SIGNS OF CORROSION WERE FOUND ON THE INSTRUMENT BEARINGS. PITCH AND GRIP INPUT DISK BEARINGS EXHIBIT ORANGE DISCOLORATION. THE INSTRUMENT WAS ALSO FOUND TO HAVE DRIED RESIDUE ON THE CLAMPING PULLEYS. THE PROBABLE ROOT CAUSE OF CABLE BREAKAGE, WHETHER PARTIAL OR FULL, IS ATTRIBUTED TO A REDUCTION IN THE ULTIMATE STRENGTH OF THE MATERIAL, WHICH MAY BE THE RESULT OF DAMAGE TO THE CABLE THROUGH EXTERNAL COLLISIONS, DURING USE, OR DURING REPROCESSING. THIS COMPLAINT IS CONSIDERED A REPORTABLE EVENT DUE TO THE FOLLOWING CONCLUSION: IT WAS REPORTED THAT A FRAYED CABLE GOT CAUGHT ON A PATIENT'S TISSUE. MEDICAL INTERVENTION MAY BE REQUIRED IN THE EVENT THAT A MOVING INSTRUMENT MECHANISM WITHIN AN INSTRUMENT ENTRAPS TISSUE AND CAUSES DAMAGE. WHILE THERE WAS NO HARM OR INJURY TO THE PATIENT, THE REPORTED FAILURE MODE COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF IT WERE TO RECUR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED INGUINAL HERNIA-UNILATERAL SURGICAL PROCEDURE, THE CUSTOMER NOTICED THAT THE PROGRASP FORCEPS INSTRUMENT STARTED GETTING CAUGHT ON THE PATIENT'S TISSUE DUE TO A FRAYED CABLE. THE CUSTOMER STOPPED USING THE INSTRUMENT AND REPLACED IT WITH ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) HAS MADE FOLLOW-UPS 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
    402375 ENDOWRIST PROGRASP FORCEPS NAY INTUITIVE SURGICAL, INC 471093-11 K11220926 0216 00886874119785

    Patients

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