BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERMANENT CAUTERY HOOK INSTRUMENT

    MDR report key: 1099849 · Received August 6, 2008

    Report

    Report Number
    2955842-2008-01196
    Event Type
    Malfunction
    Date Received
    August 6, 2008
    Report Date
    August 6, 2008
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS RETURNED AND EVALUATED. PER THE CUSTOMER REPORTED COMPLAINT, ENGINEERING FOUND THE CAUTERY HOOK TO BE BROKEN OFF AT THE BASE OF THE YAW PULLEY. THE HOOK AND CERAMIC SLEEVE WERE NOT RETURNED. A YAW PULLEY SECTION BENEATH THE CERAMIC SLEEVE WAS ALSO FOUND TO HAVE BROKEN OFF. THE HOOK FRACTURED THROUGH ONE OF THE HOLES MACHINED IN THE SHANK. ENGINEERING CONCLUDED THAT THE DAMAGE MAY BE DUE TO THE EXCESSIVE FORCES AND USER ABUSE. ENGINEERING ALSO FOUND THE MAIN TUBE TO HAVE A 1.5" LONG SECTION LOCATED 1.5" BELOW THE MIDPOINT WITH MATERIAL REMOVED ON ONE SIDE OF THE TUBE. THE DAMAGED AREA IS PARALLEL TO THE TUBE AXIS AND HAS A ROUGH SURFACE FINISH. BASED ON THE LOCATION AND APPEARANCE, THE DAMAGE WAS MOST LIKELY CAUSED BY A CANNULA ACCESSORY. NO OTHER DAMAGE FOUND. ADDITIONAL INVESTIGATION IS UNDERWAY REGARDING THE CANNULA ACCESSORIES. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PERMANENT CAUTERY HOOK INSTRUMENT WAS NOT WORKING. NO PIECES WERE REPORTED AS FALLING INTO THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED. NO PATIENT HARM, ADVERSE OUTCOME OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERMANENT CAUTERY HOOK INSTRUMENT ELECTROSURGICAL INSTRUMENT GEI INTUITIVE SURGICAL, INC. 420183-04 0712051 001

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESSORIES| ELECTROCURGICAL UNIT| DA VINCI S SURGICAL SYSTEM