BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 5147978 · Received October 14, 2015

    Report

    Report Number
    3005075853-2015-06505
    Event Type
    Malfunction
    Date Received
    October 14, 2015
    Date of Event
    September 2, 2015
    Report Date
    September 1, 2015
    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
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. BATCH # M5230G. ADDITIONAL INFORMATION REQUESTED AND RECEIVED: WAS THE PROCEDURE A LAPAROSCOPIC DUODENAL SWITCH OR A SLEEVE GASTRECTOMY? LAP DS DID THE DEVICE STAPLE? YES. IF YES, WHAT WAS THE APPEARANCE OF THE DEPLOYED STAPLES? SEE PHOTOS. WERE THERE ANY STAPLES MISSING FROM THE STAPLE LINE? UNKNOWN (SEE PHOTO) STAPLES ALL IN BUNCH INTRA-OPERATIVE PHOTO RECEIVED. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE BELIEF IS THAT THE COMPLICATION WAS PROBABLY ONE OR AN INTERACTION OF SOME COMBINATION OF THE FOLLOWING FACTORS: TISSUE THICKNESS TO CARTRIDGE MISMATCH, A MIGRANT STAPLE PICKED UP BY THE KNIFE, OR CROSSING OF AN EXISTING STAPLE LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE AFFILIATE THAT DURING A SLEEVE GASTRECTOMY PROCEDURE, ON THE FUNDUS OF THE STOMACH, WHEN THE SURGEON FIRED THE LAST FIRING, THE KNIFE OF THE STAPLER PUSHED THE TISSUE FORWARD WITHOUT TRANSACTING IT. SURGEON REMOVED STAPLER, OPENED A NEW SAME LIKE AND PLACED IN A NEW GOLD RELOAD HOWEVER THE EXACT ISSUE OCCURRED AGAIN. THE SURGEON THEN DECIDED TO OVER-SEW THE TISSUE. THE SURGICAL STAFF HAS ALSO NOTED IT IS EXTREMELY DIFFICULT TO REMOVE THE PAPER/FILM PACKAGING LAYER OF THE PRODUCT. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT REPORTED. THERE WAS A DELAY OF TWENTY MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681259 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC.

    Patients

    Seq Age Sex Outcome Treatment
    1