BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1930228 · Received December 16, 2010

    Report

    Report Number
    3005075853-2010-07203
    Event Type
    Malfunction
    Date Received
    December 16, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WAS NOT RELEASED FOR ANALYSIS BY THE CUSTOMER THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, THERE WAS A PACKAGING LOT OR BATCH NUMBER PROVIDED BY THE USER FACILITY. THE BATCH RECORDS WERE REVIEWED AND THE FINAL QUALITY RELEASE CRITERIA WAS MET BEFORE THE BATCHES WERE RELEASED FOR DISTRIBUTION. COMPLAINT INFORMATION IS TRENDED ON A REGULAR BASIS TO DETERMINE IF FURTHER INVESTIGATION IS WARRANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLON RESECTION, THE DEVICE HAD BEEN FIRED TWO TIMES. ON THE THIRD FIRING, THE STAPLES FIRED AND THE DEVICE CUT BUT WHEN THE SURGEON WENT TO PULL IT BACK, IT WOULD NOT PULL BACK. THE SURGEON HAD TO PRY THE DEVICE OPEN. THE AREA WAS OVER SEWED. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA G4U05N

    Patients

    Seq Age Sex Outcome Treatment
    1 CARTRIDGE