BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT GRIP HANDLE)

    MDR report key: 364734 · Received December 6, 2001

    Report

    Report Number
    MW1023564
    Event Type
    Malfunction
    Date Received
    December 6, 2001
    Date of Event
    November 29, 2001
    Report Date
    November 30, 2001
    Manufacturer
    CONMED CORP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HAND CONTROLLED ELECTROSURGICAL INSTRUMENT (SINGLE USE DISPOSABLE) MALFUNCTIONING DURING LAPAROSCOPIC CHOLE PROCEDURE. INSTRUMENT ACTIVATED WITHOUT DEPRESSING ROCKER-SWITCH. (INSTRUMENT WORKED CORRECTLY THROUGH PART OF CASE.) CLINICAL EQUIPMENT SVS WERE CONTACTED. THE EQUIPMENT WAS CHECKED. IT WAS DETERMINED THAT THE HAND PIECE WAS FAULTY. NO PT INJURY. PERFORMED TESTING ACCORDING TO MFG SPECS TO ISOLATE THE FAILING COMPONENT. TESTS INDICATED THE ESU ASSEMBLY WAS OPERATING PROPERLY. THE DISPOSABLE ITEM, CONMED HANDPIECE, PART NUMBER 60-6010-005 WITH LOT NUMBER OF 0110031, TESTED BAD. WHEN THE COAG SWITCH WAS ACTIVATED AND UNSTABLE 2-5 OHMS WAS OBTAINED. WHEN THE COAG SWITCH WAS RELEASED OR INACTIVE, A VERY UNSTABLE READING WAS OBTAINED FROM SEVERAL HUNDRED OHMS TO 1-2 MEG OHMS. AN OPEN LOAD WAS NEVER OBTAINED FROM THE TESTED UNIT AS IT WAS WHEN COMPARED TO ANOTHER NEW, 60-6010-005, HANDPIECE THAT WAS TAKEN OUT OF A PACKAGE. IT IS HOSP'S CONCLUSION THAT THE IMPROPER OPERATION OF THE ESU AND COMPONENTS WAS A DIRECT RESULT OF THE DISPOSABLE HANDPIECE FAILURE. THE ESU AND OTHER COMPONENTS WERE CLEARED AND DO NOT REQUIRE FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54953 MULTIFUNCTION INSTRUMENT SYSTEM (STRAIGHT GRIP HANDLE) ELECTRICAL SUCTION/IRRIGATION INSTRUMENT WITH HAND HELD ELEC GEI CONMED CORP NA 0110031

    Patients

    Seq Age Sex Outcome Treatment
    1 * 1) VALLEY LAB GENERATOR.