BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC VASCULAR LINEAR CUTTER

    MDR report key: 43994 · Received October 16, 1996

    Report

    Report Number
    1527736-1996-00273
    Event Type
    Malfunction
    Date Received
    October 16, 1996
    Report Date
    October 13, 1996
    Manufacturer
    CINNATI
    Product Code
    GAG
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    9/23/96 1306 MESSAGE AND 800# LEFT FOR MD CALL BACK. 1325 DR. CALLED BACK AND STATED THE FIRST FIRING WAS OK, THE SECOND FIRING "FELT A LITTLE ROUGH," AND THE THIRD FIRING WOULD NOT FIRE AT ALL. A NEW INSTRUMENT WAS OPENED TO COMPLETE THE CASE. A1,2,3,4,B3,6,7,D10-INFO NOT PROVIDED BY USER FACILITY. H4,D5,6-INFO NOT AVAILABLE. RESULTS OF EVALUATION: 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 BENT KNIFE. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE IT FUNCTIONS PROPERLY.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PERFORMED DURING 9/96. IT WAS REPORTED THE DEVICE WAS FIRED ON THE ADNEXA AND BROAD LIGAMENT. ON THE FIRST AND SECOND FIRINGS, THE DEVICE STAPLED HALFWAY. A SECOND DEVICE WAS INTRODUCED AND USED TO COMPLETE THE CASE. THERE WAS NO PT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other