BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL

    MDR report key: 1821139 · Received August 9, 2007

    Report

    Report Number
    1527736-2007-05280
    Event Type
    Malfunction
    Date Received
    August 9, 2007
    Date of Event
    June 27, 2007
    Report Date
    June 29, 2007
    Manufacturer
    ETHICON ENDO SURGERY, INC (CINCINNATI)
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DAMAGED JAWS. EVALUATION SUMMARY: TWO DEVICES WERE RETURNED FOR ANALYSIS. BOTH DEVICES WERE RETURNED WITH THE JAWS OVER TWISTED. THE INSTRUMENT WAS CYCLED AND EJECTED THE REMAINING CLIPS DUE TO THE CONDITION OF THE JAWS. THE INSTRUMENT LOCKED OUT AS INTENDED. THE MANUFACTURING RECORDS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ESOPHAGECTOMY PROCEDURE, THERE WAS DEFECT OF LOADING CLIP. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 LARGE TITANIUM LIGATING CL FZP ETHICON ENDO SURGERY, INC (CINCINNATI) NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1