BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** LINEAR CUTTER

    MDR report key: 4143594 · Received October 6, 2014

    Report

    Report Number
    3005075853-2014-06848
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 17, 2014
    Report Date
    September 18, 2014
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF FURTHER DETAILS ARE RECEIVED AND/OR DEVICE IS RECEIVED AND ANALYZED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SENT. AT THE TIME OF THIS SUBMISSION, THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION: A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS. NO ANALYSIS WAS PERFORMED AS ONLY 10 MALFORMED STAPLES, THE TYVEK AND BLISTER WERE RECEIVED. EVENT COULD NOT BE CONFIRMED AS NO DEVICE OR CARTRIDGE WERE RETURNED FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A COLORECTAL RESECTION PROCEDURE, WHEN THE DEVICE WAS FIRED, THE STAPLES DID NOT CLOSE AT THE DISTAL END. THE SURGEON HAS NOTED IT WAS THE FIRST FIRING, PROXIMAL STAPLES WERE ALL FINE, DISTAL STAPLES FIRED BUT NOT CLOSED AND TISSUE WAS CUT HENCE LEAVING A DEFECT. WE USED IT FOR A SECOND FIRING WITH A NEW CARTRIDGE AND THAT WAS OK. NO PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624323 PROXIMATE** LINEAR CUTTER STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA L4EX0K

    Patients

    Seq Age Sex Outcome Treatment
    1