BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER

    MDR report key: 156085 · Received March 12, 1998

    Report

    Report Number
    1527736-1998-00713
    Event Type
    Malfunction
    Date Received
    March 12, 1998
    Date of Event
    February 10, 1998
    Report Date
    February 12, 1998
    Manufacturer
    ETHICON ENDO-SURGERY, INC.
    Product Code
    GCJ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TRACKING #.49594. EES #981079/J. D5,6; H4: INFO NOT AVAILABLE. ENDOPATH DILATING TIP TROCAR: BASED UPON THE INQUIRY INFO RECEIVED AND THE VISUAL EXAMINATION, IT WAS CONFIRMED THAT THE INNER GASKET WAS DISLODGED FROM ITS ORIGINAL POSITION. NO CONCLUSION COULD BE REACHED AS TO HOW THE INNER GASKET HAD BECOME DISLODGED FROM ITS ORIGINAL POSITION.

    Description of Event or Problem · 1

    IT WAS REPRTED THE 355LD WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED BY THE AFFILIATE THE INNER GASKET FELL INTO THE PT. THE GASKET WAS RETRIEVED. THERE WAS NO CONSEQUENCE TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other