BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    MDR report key: 1984114 · Received February 10, 2011

    Report

    Report Number
    3005075853-2011-00563
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    December 8, 2010
    Report Date
    January 18, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: 02/10/2011. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. G50U8T (BATCH # FOR DEVICE B); EXP DATE = 08/22/2015. (DEVICE B): 9/22/2010. SWING TAB IN LOCKED POSITION DEVICE (A) WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL SIX DRIVERS UP WITHOUT STAPLES; THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. DEVICE (B) WAS RECEIVED IN GOOD VISUAL CONDITIONS AND WITH A RELOAD LOADED IN THE DEVICE. THE RELOAD HAD THE SWING TAB IN THE LOCKED POSITION, AND THE PROXIMAL FIVE DRIVERS UP WITHOUT STAPLES; THE REMAINING DRIVERS WERE DOWN WITH STAPLES PRESENT. IT COULD NOT BE DETERMINED IF THE REPORTED INCIDENT WAS THE RESULT OF A PREMATURE LOCKOUT, OR THE RESULT OF AN INTERRUPTED FIRING STROKE. THE SWING TABS WERE RESET AND THEN THE CARTRIDGES WERE TESTED FOR FUNCTIONALITY WITH TEST DEVICES AND BOTH FIRED AS INTENDED. WHILE NO CONCLUSION COULD BE REACHED AS TO WHAT MAY HAVE CAUSED THE REPORTED INCIDENT, IT SHOULD BE NOTED THAT 100% INSPECTION IS PERFORMED BY MEANS OF AUTOMATED VISION SYSTEM TO ENSURE THE SWING TAB IS PRESENT AND UNLOCKED. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REQUESTED ON (B)(6) 2011, (B)(6) 2011 AND (B)(6) 2011 AND TO DATE, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN OPEN COLECTOMY PROCEDURE, ON THE FIRST FIRING, THE DEVICE MADE AN UNUSUAL NOISE, BUT CUT AND STAPLED PROPERLY. THE SECOND DEVICE MADE AN UNUSUAL NOISE ON THE INITIAL FIRING, BUT THE DEVICE CUT AND STAPLED PROPERLY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE AND PERFORMED AS EXPECTED. THEN, ON DECEMBER 16TH, THE PATIENT WAS BROUGHT BACK FOR A SUSPECTED LEAK, AT THE ANASTOMOSIS, BUT THERE WAS NO LEAK AT THE ANASTOMOSIS SITE. SURGEON OVERSEWED THE NECROTIC ZONE AT THE END OF THE DESCENDING COLON. IT IS UNKNOWN WHAT CAUSED THEM TO THINK THERE WAS A LEAK AT THE ANASTOMOSIS. THEY RESECTED THE NECROTIC ZONE AND OVERSEWED THE RESECTION, AND THE PATIENT RECEIVED A COLOSTOMY, BUT OBSERVED THAT THE ANASTOMOSIS WAS INTACT AND NOT THE REASON FOR THE PATIENT GETTING THE COLOSTOMY. IT WAS INCONCLUSIVE AS TO WHY THE TISSUE WAS NECROSED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R CARTRIDGE