BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER RELOAD UNIT

    MDR report key: 82819 · Received March 11, 1997

    Report

    Report Number
    1527736-1997-00232
    Event Type
    Malfunction
    Date Received
    March 11, 1997
    Date of Event
    February 10, 1997
    Report Date
    March 10, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EES# 964520. NOTE: FACILITY WAS CONTACTED AND ALL UNK INFO ON THE INITIAL REPORT IS STILL UNK WITH THE EXCEPTION OF THE ADDED INFO ON THIS SUPPLEMENTAL REPORT. RESULTS OF EVALUATION: CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPEC WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.

    Description of Event or Problem · 1

    9/4/96 1555 THE SURGEON STATED HE PLACED A CLIP ON THE CYSTIC DUCT AND THEN SHOT A CHOLANGIOGRAM. HE AGAIN PLACED A CLIP ON THE CYSTIC DUCT AND STATED IT LOOKED AS THOUGH IT HAS SCISSORED. HE REMOVED IT AND FIRED ANOTHER WITH THE SAME RESULT. HE RE-EXAMINED THE FIRST CLIP AND THOUGHT IT LOOKED "FUNNY" SO HE THEN REMOVED IT. THE SURGEON ASKED FOR ANOTHER ER320 TO BE OPENED AND IT WORKED FINE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER RELOAD UNIT ENDOSCOPIC LINEARCUTTER RELOAD GAG ETHICON ENDO-SURGERY, INC. NA J41V7E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other