BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOWRIST

    MDR report key: 19397889 · Received May 24, 2024

    Report

    Report Number
    2955842-2024-14729
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 30, 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
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INTUITIVE SURGICAL, INC. (ISI) RECEIVED THE LARGE CLIP APPLIER INSTRUMENT AND COMPLETED THE DEVICE EVALUATION. THE INSTRUMENT WAS ANALYZED AND FOUND TO HAVE A BROKEN GRIP CABLE AT THE IDLER PULLEYS. THE CABLE WAS FULLY BROKEN. THERE WAS NO EVIDENCE OF DISCOLORATION OR CORROSION/CONTAMINATION ON THE CABLES TO INDICATE A REPROCESSING INDUCED ISSUE. THE COMPONENTS SURROUNDING THE BROKEN CABLE DID NOT EXHIBIT ABNORMAL SHARP EDGES OR DAMAGE THAT WOULD HAVE CONTRIBUTED TO THE CABLE BREAKING. A REVIEW OF THE PROVIDED IMAGE WAS PERFORMED BY AN ISI FAILURE ANALYSIS ENGINEER (FAE). THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: IT LOOKED LIKE A BROKEN GRIP CABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED CHOLECYSTECTOMY SURGICAL PROCEDURE, THE LARGE CLIP APPLIER INSTRUMENT WIRE BROKE WHILE THE CUSTOMER ATTEMPTED TO USE IT. THERE WAS NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INSTRUMENT WAS INSPECTED PRIOR TO USE AND LOOKED FINE. THE ISSUE OCCURRED WHILE THE SURGEON ATTEMPTED TO CLAMP ON A VESSEL OR TISSUE BUNDLE. THE PROCEDURE WAS COMPLETED ROBOTICALLY AFTER THEY OPENED ANOTHER CLIP APPLIER INSTRUMENT. NO FRAGMENTS FELL INSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658045 ENDOWRIST LARGE HEM-O-LOK CLIP APPLIER NAY INTUITIVE SURGICAL, INC 470230-12 N10201027 0016 00886874112380

    Patients

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