BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM

    MDR report key: 1431618 · Received May 6, 2009

    Report

    Report Number
    3005075853-2009-02744
    Event Type
    Malfunction
    Date Received
    May 6, 2009
    Date of Event
    March 12, 2009
    Report Date
    April 14, 2009
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDO
    PMA / PMN Number
    K820837
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). EVALUATION SUMMARY: THE MULTIPLE CLIP APPLIER MSM20 (A) WAS VISUALLY AND FUNCTIONALLY EVALUATED AND NO ANOMALIES WERE NOTED; IT FED AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING REQUIREMENTS WHEN TESTED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO MFG REQUIREMENTS. ALTHOUGH NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT, CHANGE TO OPTIMIZE THE INSTRUMENT CLIP FORMING MECHANISM IS BEING PURSED TO MINIMIZE THE RISK OF THIS TYPE OF ISSUE. 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. THE MULTIPLE CLIP APPLIER MSM20 (B) WAS VISUALLY AND FUNCTIONALLY EVALUATED AND NO ANOMALIES WERE NOTED; IT FED AND FORMED THE REMAINING CLIPS WITHIN MANUFACTURING REQUIREMENTS WHEN TESTED. THE INSTRUMENT WAS FULLY FUNCTIONAL AND CONFORMING TO MFG REQUIREMENTS. ALTHOUGH NO CONCLUSION COULD BE REACHED BASED ON THE ANALYSIS RESULTS AS TO WHAT MAY HAVE CAUSED THE REPORTED EVENT, CHANGE TO OPTIMIZE THE INSTRUMENT CLIP FORMING MECHANISM IS BEING PURSED TO MINIMIZE THE RISK OF THIS TYPE OF ISSUE. 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. DEVICE B ADDITIONAL INFORMATION: BATCH # F9G028. EXPIRATION DATE: 12/2014. MANUFACTURING DATE: 01/2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED DURING A DIEP FLAP PROCEDURE. THE DEVICES WERE CUTTING VESSEL AND/OR JAMMING. 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 MCA MULTIPLE CLIP APPLIER - 23.8 CM, 20 MEDIUM GDO ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1