BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 3112376 · Received May 14, 2013

    Report

    Report Number
    3005075853-2013-02321
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 19, 2013
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    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. ONLY YEAR AND MONTH KNOWN, ASSUMED 1ST DAY OF MONTH THAT COMPLAINT WAS REPORTED ADDITIONAL INFORMATION REQUESTED AND RECEIVED: ON WHAT TISSUE TYPE WAS THE DEVICE USED? STOMACH AT WHAT LOCATION ON THE TISSUE? ASKU. WAS THE DEVICE FIRED ON TISSUE THAT HAD BEEN RADIATED OR HAS THE PATIENT BEEN TAKING SYSTEMIC STEROIDS? ASKU. ON WHICH FIRING(S) DID THIS EVENT OCCUR (1ST, 2ND, 12TH, ETC)? ASKU. WHAT COLOR CARTRIDGE WAS BEING USED? BLUE. WHAT OTHER COLOR CARTRIDGES WERE USED BEFORE AND AFTER THIS EVENT? GREEN. WAS BUTTRESSING MATERIAL UTILIZED? ASKU. IF SO, WHICH PRODUCT? WAS THE INSTRUMENT FIRED ACROSS OR NEAR AN EXISTING STAPLE LINE OR CLIP? YES. WERE ANY UNEXPECTED NOISES HEARD? ASKU. IF SO, WHEN? WERE ANY OF THE FORCES HIGHER OR LOWER THAN EXPECTED (CLOSING, FIRING, OR OPENING)? ASKU. AFTER USE, DID EACH OF THE TRIGGERS AND BUTTONS AUTOMATICALLY RETURN TO THEIR ORIGINAL (PRE-FIRED) POSITIONS, WITHOUT INTERVENTION? DEVICE POWERED BACK IN NORMAL RETURN. WAS THERE ANY DIFFICULTY REMOVING THE DEVICE FROM THE TISSUE? ASKU.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS SHOWED THAT FIVE CARTRIDGE RELOADS WERE RECEIVED. THE RELOADS WERE RECEIVED IN GOOD VISUAL CONDITION AND FULLY FIRED. IN ADDITION THE RETURNED RELOAD WAS DISASSEMBLED TO VERIFY THE CONDITION OF THE INTERNAL COMPONENTS AND NO ANOMALIES WERE NOTED. NO FUNCTIONAL TEST COULD BE PERFORMED DUE TO THE CONDITION OF THE RELOADS. EVENT COULD NOT BE CONFIRMED AS NO DEVICE WAS RETURNED FOR ANALYSIS. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS. BATCH: K59E30, MANUFACTURING DATE:02/04/2013, PRODUCT EXP. DATE:01/04/2018.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SLEEVE GASTRECTOMY PROCEDURE THE SURGEON WAS FIRING THE DEVICE FOR THE LAST FIRING WITH A BLUE CARTRIDGE. WHEN HE REMOVED THE DEVICE THERE WAS BLEEDING AND HE OBSERVED THAT THE DEVICE CUT THE TISSUE BUT DID NOT STAPLE PART OF THE CUT LINE. HE THEN OVER SEWED THE AREA WITH SUTURE AND COMPLETED THE PROCEDURE TO CONTROL THE BLEEDING. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213223 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 ECR60G (FIVE RELOADS RETURNING) LOT#: UNKNOWN