BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MCA MED LONG APPLIER

    MDR report key: 2072038 · Received April 28, 2011

    Report

    Report Number
    3005075853-2011-01769
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 4, 2011
    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

    (B)(4): INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. THREE ATTEMPTS WERE 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. THE COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE MANUFACTURING CRITERIA WAS MET PRIOR TO THE RELEASE OF THE BATCHES INCLUDED IN THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THERE WERE MALFORMED CLIPS-SCISSORED. DURING A LUNG SAMPLING (FOR A MULTI SAMPLING ORGAN) THE CLIPS CUT A BRONCHIAL ARTERY WHEN IT CLOSED. IT OCCURRED AN IMPORTANT BLEEDING AND A RISK FOR THE SAMPLING. THE SAMPLING COULD BE PERFORMED WITHOUT FURTHER ISSUES. NO MORE DETAILS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MCA MED LONG APPLIER CLIP, IMPLANTABLE GDO ETHICON ENDO-SURGERY, LLC. NA G4UD5M

    Patients

    Seq Age Sex Outcome Treatment
    1