BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER

    MDR report key: 82203 · Received March 3, 1997

    Report

    Report Number
    1628808-1997-00104
    Event Type
    Malfunction
    Date Received
    March 3, 1997
    Date of Event
    January 31, 1997
    Report Date
    March 3, 1997
    Manufacturer
    EES-ALBUQUERQUE
    Product Code
    GDO
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED UPON THE 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 THE PRODUCTS.

    Description of Event or Problem · 1

    DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CLIPS ON THE ER320 WERE BENT SCISSORED WHEN CLOSING DOWN. A NEW ER320 WAS USED TO COMPLETE THE CASE. THERE WAS NO CONSEQUENCE TO THE PT. CLINICAL FOLLOW UP: 2/4/97 1440 MESSAGE AND 800 NUMBER LEFT FOR SURGEON TO CALL BACK. 2/4/97 1638 SURGEON CALLED BACK AND CONFIRMED THE INFO AS REPORTED BY THE REP. SURGEON STATED HE DID NOT NOTICE THE SCISSORING UNTIL THE 5TH FIRING WHEN THE INSTRUMENT "FIRED STRANGE". THE CLIP WAS NOTED TO BE SCISSORED "REALLY BAD". HE THEN REMOVED THE 5TH CLIP AND NOTED ALL PREVIOUS CLIPS WERE ALSO SCISSORED. THEY WERE REMOVED AND ANOTHER INSTRUMENT WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC MULTIPLE CLIP APPLIER ENDOSCOPIC CLIP APPLIER GDO EES-ALBUQUERQUE NA J44W1V

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other