BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIGAMAX-5MM

    MDR report key: 2221410 · Received August 24, 2011

    Report

    Report Number
    3005075853-2011-03470
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    April 25, 2011
    Report Date
    August 3, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    FZP
    PMA / PMN Number
    K864102
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONTACT AT THE FACILITY WAS UNABLE TO PROVIDE FURTHER DETAILS REGARDING THE EVENT. SHE PROVIDED AN ADDITIONAL CONTACT; HOWEVER, NO RESPONSE HAS BEEN OBTAINED FROM THE REQUEST FOR ADDITIONAL DETAILS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. AN EL5ML DEVICE WAS RECEIVED INSTEAD OF THE REPORTED ER320. THE DEVICE WAS RECEIVED IN GOOD VISUAL CONDITION. WHEN TESTING THE DEVICE FOR FUNCTIONALITY IT WAS NOTED TO BE EMPTY AND LOCKED OUT AS INTENDED. THE DEVICE WAS DISASSEMBLED AND NO ANOMALIES WERE NOTED WITH THE INTERNAL COMPONENTS. NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGAMAX-5MM LIGAMAX-5MM FZP ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1