BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 98197 · Received June 12, 1997

    Report

    Report Number
    1527736-1997-01274
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    April 4, 1997
    Report Date
    June 11, 1997
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    FACILITY EXPERIENCED AN EVENT WITH LIGACLIP* ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER ON 4/4/97 WHILE PERFORMING A UNKNOWN PROCEDURE. THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973527. THE RESULTS OF THE INVESTIGATION CONDUCTED BY THE APPROPRIATE ENGINEERS AND TECHNICIANS ARE LISTED BELOW. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW, YES; DAMAGED JAWS, NO; DAMAGED FEED BAR, NO; DAMAGED FLOOR, NO; DAMAGED HANDLE SHROUDS, 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; FIRIING: FORM CONFORM, YES; JAWS: HOLD CLIP, YES; JAWS: INSIDE WIDTH AT TIPS, .216; LOCKOUT FUNCTIONAL, YES AND NUMBER OF CLIPS FED AND FORMED, 6. ANALYSIS CONCLUSION: BASED UPON THE INQUIRY INFO RECEIVED, THE VISUAL EXAMINATION, AND THE FUNCTIONAL TESTING, NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE INSTRUMENT WAS RETURNED IN GOOD PHYSICAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE CLIPS WITHIN DESIGN SPECIFICATION WHEN TESTED. IT WAS CONCLUDED THAT THE INSTRUMENT WAS CONFORMING TO DESIGN SPECIFICATIONS. THE EXPERIENCE THE SURGEON REPORTED COULD NOT BE REPEATED. EACH INSTRUMENT 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 IMRPOVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING AN UNKNOWN PROCEDURE. THE CLIPS DROPPED FROM THE JAWS. THE CLIPS DID NOT FALL INTO THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other