BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19338257 · Received May 17, 2024

    Report

    Report Number
    2955842-2024-14587
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 16, 2024
    Report Date
    April 17, 2024
    Manufacturer
    INTUITIVE SURGICAL, INC
    Product Code
    NAY
    UDI-DI
    00886874112380
    PMA / PMN Number
    K131861
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) DID RECEIVE THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT TO PERFORM FAILURE ANALYSIS AND THE COMPLAINT WAS CONFIRMED. THE INSTRUMENT WAS ANALYZED AND FOUND WITH A BROKEN GRIP CABLE AT THE PROXIMAL END CAUSING THE CABLE ON THE DISTAL TO BECOME LOOSE. THE INSTRUMENT WAS FOUND TO HAVE MULTIPLE GRIP CABLES BROKEN AT THE PROXIMAL END IN THE HOUSING. THE GRIP CABLE WAS BROKEN AT THE CLAMPING PULLEY/BACKEND PULLEYS. THE CLAMPING PULLEYS DID NOT EXHIBIT SIGNS OF CORROSION/CONTAMINATION/RESIDUE THAT WOULD HAVE CONTRIBUTED TO THE BROKEN CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE HEM-O-LOK CLIP APPLIER INSTRUMENT CABLE SNAPPED WHILE ATTEMPTING TO APPLY THE CLIP. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE WITH NO NOTED DAMAGE. THE CLIP DID NOT DISLODGE OR FALL INTO THE PATIENT. A TELEFLEX LLC, LARGE INTERNAL HEM-O-LOK CLIP WAS THE TYPE OF CLIP USED. THE ISSUE OCCURRED ON THE THIRD CLIP APPLICATION. THE SURGEON USED A BACK UP TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519672 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 K11220117 0098 00886874112380

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose DA VINCI INSTRUMENTS AND ACCESSORIES