BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 41667 · Received August 30, 1996

    Report

    Report Number
    1527736-1996-00071
    Event Type
    Malfunction
    Date Received
    August 30, 1996
    Date of Event
    August 7, 1996
    Report Date
    August 29, 1996
    Manufacturer
    NA
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    F1: SHOULD NOT HAVE BEEN CHECKED ON INITIAL MEDWATCH. NO MEDWATCH WAS RECEIVED BY USER FACILITY. H4: INFO NOT AVAILABLE H6: CODE 400 (OTHER): DAMAGED FIRING MECHANISM G3: CONSUMER WAS INCORRECTLY SELECTED ON INITIAL MEDWATCH CONCLUSION BASED UPON INFO RECEIVED AND VISUAL EXAMINATION, IT WAS CONCLUDED THAT INSTRUMENT WAS RETURNED NON-FUNCTIONAL. INSTRUMENT WAS DISASSEMBLED AND FOUND TO HAVE A DAMAGED FIRING MECHANISM. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS SOME CONSITONS WHICH MIGHT RESULT IN DAMAGE TO FIRING MECHANISM ARE: INTERRUPTED FIRING CYCLE, TISSUE THICKER THAN INDICATED, ATTEMPTING TO FIRE THROUGH A SPENT CARTRIDGE, FIRING PRIOR TO COMPLETE CLAMPING OF JAWS AND FAILURE TO PROPERLY FOLLOW RELOADING INSTRUCTIONS. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE ITS PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNK PROCEDURE. THE EZ35B DID NOT CLAMP AND DID NOT CUT. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDOSCOPIC LINEAR CUTTER GAG NA NA HC5049

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other