BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX CLIP APPLIER

    MDR report key: 4048475 · Received August 29, 2014

    Report

    Report Number
    3005075853-2014-06079
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Report Date
    August 18, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K050344
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE EL5ML WAS RETURNED FOR ANALYSIS IN GOOD PHYSICAL CONDITION. UPON VISUAL INSPECTION, THE INSTRUMENT WAS NOTED TO HAVE EXCESSIVE DRIED BODY FLUIDS. DURING THE ANALYSIS, THE DEVICE WAS CYCLED AND IT FED AND FORMED ONE CLIP WITH GAP; UPON THE FIRST ACTUATION, DRIED BODY FLUIDS CAME OFF FROM THE SHAFT. THE INSTRUMENT WAS CYCLED AND IT FED AND FORMED TWO CONFORMING CLIPS INTERMITTENTLY. THE DEVICE KEPT BEING CYCLED AND NO CLIPS WERE FED INTO THE JAWS; THEREFORE THE LOCKOUT MECHANISM COULD NOT BE TESTED. THE DEVICE WAS DISASSEMBLED IN ORDER TO EVALUATE THE CONDITION OF THE INTERNAL COMPONENTS; UPON DISASSEMBLING, EXCESSIVE DRIED BODY FLUIDS WERE NOTED TO BE INSIDE THE HANDLES AND THE SHAFT OF THE DEVICE. IT IS POSSIBLE THAT THE DRIED BODY FLUIDS COULD HAVE PREVENTED TO PROPER FEEDING OF THE CLIPS INTO THE JAWS, AS WELL AS THE CORRECT FORMATION OF THE CLIPS. ACCUMULATION OF BODY FLUIDS IS A ROUTINE OCCURRENCE DURING SURGICAL PROCEDURES AND DOES NOT NECESSARILY INDICATE A MANUFACTURING DEFECT IN THE DEVICE. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC SIGMA PROCEDURE, THERE WERE MISFORMED CLIPS. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530663 LIGAMAX CLIP APPLIER CLIP, IMPLANTABLE FZP ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1