BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGACLIP MCA SMALL APPLIER

    MDR report key: 1080337 · Received July 24, 2008

    Report

    Report Number
    3005075853-2008-00313
    Event Type
    Malfunction
    Date Received
    July 24, 2008
    Date of Event
    April 10, 2008
    Report Date
    April 21, 2008
    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
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MISASSEMBLE HOOP SPRING. EVAL SUMMARY: THE ANALYSIS RESULTS FOR THE MCS20 INSTRUMENT CONFIRMED THAT IT WAS RETURNED NON-FUNCTIONAL. THE INSTRUMENT WAS CYCLED AND WOULD NOT FEED THE CLIPS. IN ADDITION THE ANTI-BACKUP WAS NOTED TO BE NON-FUNCTIONAL. UPON DISASSEMBLY OF THE INSTRUMENT THE HOOP SPRING WAS FOUND DISENGAGED, THEREFORE, NOT ALLOWING THE PROPER CYCLING OF THE INSTRUMENT. WE HAVE DOCUMENTED THE CIRCUMSTANCES AS THEY WERE REPORTED TO US. IN ADDITION, COMPLAINT INFO 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 MFG PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, CLIPS WOULD NOT ADVANCE. THE DEVICE RELEASED JUST 5 CLIPS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGACLIP MCA SMALL APPLIER NONE GDO ETHICON ENDO-SURGERY, LLC NA D4K561

    Patients

    Seq Age Sex Outcome Treatment
    1