BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IDRIVE ULTRA POWERED HANDLE 1

    MDR report key: 3190166 · Received June 10, 2013

    Report

    Report Number
    1219930-2013-00397
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 13, 2013
    Report Date
    May 13, 2013
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL
    Product Code
    GDW
    PMA / PMN Number
    K121510
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: LAPAROSCOPIC SLEEVE GASTRECTOMY. ACCORDING TO THE REPORTER: THREE FIRES WERE MADE PROPERLY, BUT WHEN THE SURGEON WAS READY TO MAKE THE FOURTH FIRE, HE DID NOT REALIZE THAT THE BOUGIE TUBE HAD DONE A LOOP. THEREFORE, THE BOUGIE TUBE WAS GRASPED AT THE TIP OF THE CARTRIDGE WHEN THE SURGEON CLOSED THE JAWS. THE SURGEON THOUGHT THAT EVERYTHING WAS OK, AND STARTED THE FIRE. AFTER THAT, HE REALIZED THAT THERE WAS A SMALL HOLE AT THE WALL GASTRIC (ABOUT 5 MM), JUST AT THE END OF THE STAPLER LINE. THE SURGEON WAS ABLE TO SOLVE THE PROBLEM BECAUSE THE BOUGIE TUBE WAS NOT STAPLED, AND THE SURGEON ONLY HAD A SMALL CUT ON IT (ABOUT 3 MM), SO THE BOUGIE TUBE WAS FREE. THE SURGEON SEWED UP THE WALL GASTRIC HOLE WITH TWO STITCHES. AFTER THAT, TWO MORE FIRES WERE MADE PROPERLY. THERE WAS NOT ANY MORE INCIDENT AT THE PROCEDURE. THERE WAS NO REINFORCEMENT MATERIAL USED IN CONJUNCTION WITH THE STAPLING DEVICE. THERE WAS NO UNANTICIPATED TISSUE LOSS AS A RESULT OF THIS PROBLEM. THERE WAS NO BLEEDING, NO TISSUE DAMAGED AND/OR NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261880 IDRIVE ULTRA POWERED HANDLE 1 SURGICAL STAPLER GDW COVIDIEN, FORMERLY US SURGICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 K#121510| EGIA60AVM, EGIA 60 ARTICULATING VAS/MED SULU,