BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE-SITE PERMANENT CAUTERYHOOK INSTRUMENT

    MDR report key: 3844217 · Received June 2, 2014

    Report

    Report Number
    2955842-2014-03393
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 5, 2014
    Manufacturer
    INTUITIVE SURGICAL,INC.
    Product Code
    NAY
    PMA / PMN Number
    K130726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, FAILURE ANALYSIS INVESTIGATION FOUND THE HOOK BROKEN AROUND THE CIRCUMFERENCE OF THE HOOK ASSEMBLY AT THE DISTAL END. THE BROKEN PIECE WAS RETURNED WITH INSTRUMENT WITH NO MISSING PIECES. FAILURE ANALYSIS CONCLUDED THE DAMAGE WAS LIKELY DUE TO MISHANDLING / MISUSE. NO OTHER DAMAGE WAS FOUND. THE CUSTOMER REPORTED COMPLAINT DOES NOT ITSELF CONSTITUTE A MDR REPORTABLE EVENT; HOWEVER; THE BROKEN HOOK COULD LIKELY CAUSE OR CONTRIBUTE TO AN ADVERSE EVENT IF THE FAILURE MODE WERE TO RECUR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DA VINCI CHOLECYSTECTOMY PROCEDURE, THE TIP OF THE SINGLE-SITE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOTED TO BE CRACKED BELOW THE HOOK ON THE PLASTIC TIP. THE TIP EVENTUALLY FELL OFF IN TRANSIT TO THE BIOMEDICAL DEPARTMENT. NOTHING REPORTEDLY FELL INTO A PATIENT. THE PLANNED SURGICAL PROCEDURE WAS COMPLETED AND NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322272 SINGLE-SITE PERMANENT CAUTERYHOOK INSTRUMENT ENDOSCOPIC ELECTROSURGICAL INSTRUMENT NAY INTUITIVE SURGICAL,INC. 428090-12 S10131205 799

    Patients

    Seq Age Sex Outcome Treatment
    1