BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 103148 · Received July 2, 1997

    Report

    Report Number
    1527736-1997-01475
    Event Type
    Malfunction
    Date Received
    July 2, 1997
    Report Date
    July 1, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973441. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW, NO; DAMAGED JAWS, YES; DAMAGED CUTTER, N/A; DAMAGED FEED BAR, NO; DAMAGED FLOOR, NO; DAMAGED HANDLE SHROUDS, NO; DAMAGED OTHER, NO; DAMAGED TIP SHROUDS, NO; DAMAGED TRIGGER, NO; DAMAGED TUBE, NO AND DAMAGED WELD SEAMS, NO. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, YES; FIRING: FEED CONFORM, YES; FIRING: FORM CONFORM, NO; JAWS: HOLD CLIP, YES; JAWS: INSIDE WIDTH AT TIPS, .222 AND LOCKOUT FUNCTIONAL, YES. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL FUNCTIONAL RESULTS, IT WAS CONCLUDED THAT THE JAWS HAD BECOME DAMAGED AND WOULD NOT FORM THE CLIPS PROPERLY. NO CONCLUSION COULD BE REACHED AS TO HOW THE DAMAGE TO THE JAWS OCCURRED. IF THE JAWS ARE CLOSED OVER A HARD OBJECT, THE JAWS CAN BECOME DAMAGED AND WILL NOT FORM THE CLIPS PROPERLY. EACH INSTRUEMNT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY. CO STRIVES TO UNDERSTAND EACH INCIDENT AS IT OCCURS IN ORDER TO CONTINUOUSLY IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED (GAPPED). THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO ETHICON ENDO-SURGERY, INC. NA K46C88

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other