BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC LINEAR CUTTER

    MDR report key: 82252 · Received February 19, 1997

    Report

    Report Number
    1527736-1997-00157
    Event Type
    Malfunction
    Date Received
    February 19, 1997
    Date of Event
    December 5, 1996
    Report Date
    February 19, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6; CODE 400: DAMAGED FIRING MECHANISM/BENT KNIFE. CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE REPORTED INCIDENT MAY HAVE BEEN CAUSED BY DAMAGE TO THE INTERNAL COMPONENTS. THE INSTRUMENT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS DISASSEMBLED AND WAS FOUND TO HAVE A BROKEN FIRING BELT. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. COMMENTS: EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    DURING A LOW ANTERIOR RESECTION THE ELC60 MISFIRED ON THE THIRD FIRING OVER THE RECTAL STUMP. IT FIRED HALFWAY AND WOULD NOT CONTINUE. A SECOND DEVICE WAS OPENED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. 1/21/97 1356 MESSAGE AND 800# LEFT FOR SURGEON TO CALL BACK. 1/22/97 1356 SURGEON CALLED BACK AND STATED HE DOES NOT RECALL THE SPECIFICS OF THE EVENT. THE CONCURRED WITH REP EXPLANATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC LINEAR CUTTER ENDCOSCOPIC LINEAR CUTTER GAG ETHICON ENDO-SURGERY, INC. NA J0076E

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other