BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GOLD RELOAD

    MDR report key: 2211415 · Received August 15, 2011

    Report

    Report Number
    3005075853-2011-03294
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE PIECE SLED. THE ECR60D RELOAD WAS RECEIVED FOR ANALYSIS WITH THE ONE-PIECE SLED DAMAGED AND FULLY LOADED WITH STAPLES. IMPROPER LOADING OF THE RELOAD MAY DAMAGE THE SLED. IF THE RELOAD IS NOT FULLY SEATED WHEN THE DEVICE IS CLOSED, THE SLED WILL BREAK. WHEN INSERTING THE RELOAD, SLIDE IT AGAINST THE BOTTOM OF THE RELOAD JAW UNTIL THE RELOAD ALIGNMENT TAB STOPS IN THE RELOAD ALIGNMENT SLOT. SNAP THE RELOAD SECURELY IN PLACE. THE INSTRUMENT IS NOW LOADED AND READY FOR USE. PLEASE REFERENCE THE INSTRUCTION FOR USE FOR THE COMPLETE GUIDE TO LOADING AND RELOADING THE INSTRUMENT. DUE TO THE CONDITION OF THE RELOAD, NO FUNCTIONAL TEST COULD BE PERFORMED. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RECEIVED FOR ANALYSIS. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, THERE WAS STAPLE MALFORMATION CAUSING THE DEVICE TO LOCK UP. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. ADDITIONAL FOLLOWUP: DID THE DEVICE LOCK OUT? YES, THE DEVICE WAS LOCKED OUT FOR CARTRIDGE. ON WHAT TISSUE TYPE WAS THE DEVICE USED? RECTUM/THICK TISSUE. AT WHAT LOCATION ON THE TISSUE? LOW ANTERIOR RECTUM. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? NO. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? 1ST. IF ECHELON, DURING WHICH STROKE DID THE EVENT OCCUR? JUST AFTER PRE COMPRESSION STROKE. WHAT COLOR CARTRIDGE WAS BEING USED? GOLD. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NO OTHER PRODUCT BEFORE THIS. WAS BUTTRESSING MATERIAL UTILIZED? NO. IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO, VESSEL SEALING WAS COMPLETED WITH LIGASURE. WERE ANY UNEXPECTED NOISES HEARD? NO. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? NO. THERE WEREN'T. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? IT OCCURRED ON 1ST STROKE, SO SURGEON USED KNIFE RETURN BUTTON. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? - LITTLE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOLD RELOAD STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK H43K33

    Patients

    Seq Age Sex Outcome Treatment
    1