BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 107236 · Received July 21, 1997

    Report

    Report Number
    1527736-1997-01733
    Event Type
    Malfunction
    Date Received
    July 21, 1997
    Report Date
    May 29, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    D5,6;H3,4,6;G4: ADDED ADDITIONAL INFO. D6: DEVICE RETURNED WITH NO LOT ID. VISUAL INSPECTIONS 7 RESULTS: CLIP IN JAWS, AEFGH-NO BCD-YES; DAMAGED JAWS, DAMAGED FEED BAR, DAMAGED FLOOR, DAMAGED HANDLE SHROUDS, DAMAGED TIP SHROUDS, DAMAGED TRIGGER, DAMAGED TUBE, AND DAMAGED WELD SEAMS, A-H NO; DAMAGED CUTTER, NA; AND DAMAGED OTHER, AE-BROKEN TOP AND. FUNCTIONAL TESTS & RESULTS: ANTIBACKUP FUNCTIONAL, FIRING: FEED AND FORM CONFORM, JAWS: HOLD CLIP, AND LOCKOUT FUNCTIONAL, ACDFGH-YES BE-NA; AND NUMBER OF CLIPS FED AND FORMED, A-11 C-6 D-3 FGH-21. ANALYSIS CONCLUSION: BASED ON THE INFO RECEIVED AND THE VISUAL AND FUNCTIONAL INSPECTION, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THERE WERE EIGHT INSTRUMENTS RETURNED, THREE OF WHICH WERE IN THE STERILE BLISTER. TWO OF THE INSTRUMENTS WERE RETURNED EMPTY AND LOCKED OUT, THEREFORE FURTHER FUNCTIONAL TESTING COULD NOT BE PERFORMED ON THE EMPTY INSTRUMENTS. THE REMAINING SIX INSTRUMENTS WERE FIRED AND ALL FIRED AND FORMED THE CLIPS AND DESIGNED WITH NO DIFFICULTIES NOTED. IT COULD NOT BE ASCERTAINED AS TO WHY THE CLIPS REPORTEDLY MALFORMED. EACH INSTRUMENT IS EVALUATED DURING THE ASSEMBLY PROCESS TO ENSURE THE CLIPS FEED AND FORM PROPERLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICES WERE USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. IT WAS REPORTED BY THE AFFILIATE THAT THE CLIPS WERE MALFORMED. THIS CAUSED THE CLIPS TO FALL FROM THE JAWS OF THE DEVICES. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other