BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 98215 · Received June 12, 1997

    Report

    Report Number
    1527736-1997-01265
    Event Type
    Malfunction
    Date Received
    June 12, 1997
    Date of Event
    March 26, 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
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT COMPLAINT ANALYSIS TEAM HAS COMPLETED ITS INVESTIGATION OF THE DEVICE WHICH WAS RETURNED TO CO WITH PRODUCT INQUIRY #973508. VISUAL INSPECTIONS & RESULTS: CLIP IN JAW, NO; DAMAGED JAWS, NO; 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 YES; JAWS: HOLD CLIP, YES; JAWS: INSIDE WIDTH AT TIPS, .175; LOCKOUT FUNCTIONAL, YES AND NUMBER OF CLIPS FED AND FORMED, 13. 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 CYCLED, FED AND FORMED THE REMAINING CLIPS AS DESIGNED. 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 IMPROVE CO'S PRODUCTS.

    Description of Event or Problem · 1

    THE DEVICE WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE. THE DEVICE WAS SPITTING CLIPS. THE CLIPS DID NOT FALL INTO THE PT. A NEW DEVICE WAS USED TO COMPLETE THE CASE. 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 J45N6R

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other