BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA

    MDR report key: 1081062 · Received July 21, 2008

    Report

    Report Number
    3005075853-2008-00589
    Event Type
    Malfunction
    Date Received
    July 21, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT: 07/21/2008. EVALUATION SUMMARY: THE ER320 INSTRUMENT WAS RETURNED IN GOOD VISUAL CONDITION. THE INSTRUMENT WAS CYCLED, FED, AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING REQUIREMENTS WHEN TESTED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO MANUFACTURING REQUIREMENTS. WHILE WE WERE UNABLE TO RECREATE THE EVENT, WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE DEVICE DID NOT WORK PROPERLY. THE CUSTOMER NOTED A MALFORMED CLIP CURRENTLY IN THE JAWS OF THE INSTRUMENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20 MEDIUM-LARGE TITANIUM LIGA FZP ETHICON ENDO-SURGERY, LLC. NA E4L823

    Patients

    Seq Age Sex Outcome Treatment
    1