BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3113854 · Received May 15, 2013

    Report

    Report Number
    3005075853-2013-02343
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    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
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE WAS RETURNED IN GOOD VISUAL CONDITION AND WITH NO RELOAD PRESENT ON THE DEVICE. THE DEVICE WAS TESTED FOR FUNCTIONALITY WITH A TEST RELOAD AND IT FIRED, CUT AND FORMED THE STAPLES AS INTENDED. THE DEVICE FIRED WITHOUT ANY DIFFICULTIES, THE STAPLE LINE WAS COMPLETE, THE CUT LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. EVENT COULD NOT BE CONFIRMED AS THE DEVICE CLOSED AND OPENED WITHOUT ANY DIFFICULTIES NOTED. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. WHEN ADDITIONAL INFORMATION IS RECEIVED AND/OR THE DEVICE ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? AT WHAT LOCATION ON THE TISSUE? OMENTUM. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 8TH, ETC.)? 1ST. WHAT COLOR CARTRIDGE WAS BEING USED? WHITE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? NA. WAS BUTTRESSING MATERIAL UTILIZED? IF SO, WHICH PRODUCT? NO. WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? NO. WERE ANY UNEXPECTED NOISES HEARD? IF SO, WHEN? NO. WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? WOULD NOT OPEN. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? NO. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? YES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THE DEVICE WAS TOO SHORT TO REACH THE TARGET TISSUE. THE DEVICE WAS CLOSED BEFORE FIRING, ATTEMPTED TO RE-OPEN BUT IT WOULD NOT OPEN. ANOTHER DEVICE WAS OPENED AND FIRED ON EACH SIDE TO REMOVE THE DEVICE. THE PROCEDURE WAS COMPLETED USING THE SECOND DEVICE. NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214385 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 TR45W