BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 58466 · Received December 18, 1996

    Report

    Report Number
    1628808-1996-00280
    Event Type
    Malfunction
    Date Received
    December 18, 1996
    Date of Event
    July 24, 1996
    Report Date
    December 17, 1996
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    H6: CODE 400(OTHER); YIELDED JAWS. RESULTS OF EVALUATION: CONCLUSION; BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND COULD NOT HOLD A CLIP PROPERLY, MAKING THE INSTRUMENT NON-FUNCTIONAL. NO CONCLUSION COULD BE REACHED AS TO HOW THIS DAMAGE OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECTT, THE JAWS CAN BECOME DAMAGED AND WILL NOT HOLD A CLIP PROPERLY. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE JAWS HOLD CLIPS PROPERLY.

    Description of Event or Problem · 1

    THE DEVICE WAS USED ON AN UNREPORTED PROCEDURE. THE ER320 CLIPS DID NOT FORM TIGHTLY. THERE WAS NO CONSEQUENCE TO THE PT. 12/2/96 1351 SURGEON CALLED BACK AND CONFIRMED THE INFO AS REPORTED BY THE REP. HE STATED THERE WAS NO DIFFICULTY IN FIRING THE INSTRUMENT, BUT WHEN THE CLIP WAS INSPECTED, IT SLID EASILY OFF THE STRUCTURE. IT WAS DIFFICULT TO NOTE THE MALFORMATION UNTIL CLOSE OBSERVATION. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA J43593

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other