BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA

    MDR report key: 7510702 · Received May 14, 2018

    Report

    Report Number
    2647580-2018-02454
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    April 5, 2018
    Report Date
    October 3, 2018
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523007237
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF DEVICE WITH SINGLE USE RELOADABLE STAPLER. VISUAL AND PHOTOGRAPHIC INSPECTION NOTED THE SINGLE USE LOADING UNIT (SULU) WAS RECEIVED PARTIALLY APPLIED WITH THE INTERLOCK ENGAGED. MICROSCOPIC INSPECTION OF THE KNIFE BLADE DISPLAYED DAMAGE. THE SINGLE USE LOADING UNIT (SULU) WAS RESET AND LOADED INTO THE RETURNED DEVICE. THE SINGLE USE LOADING UNIT (SULU) AND INSTRUMENT WERE APPLIED TO TEST MEDIA WITH ACCEPTABLE RESULTS. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THE PRODUCT WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY OCCUR IF THE FIRING STROKE IS NOT COMPLETE AND THE FIRING KNOB IS NOT FULLY RETRACTED AFTER FIRING OR IF THE INSTRUMENT IS APPLIED AGAINST AN EXCESSIVE AMOUNT OF TISSUE DURING THE CLINICAL APPLICATION. IF THE FIRING KNOB IS NOT FULLY RETRACTED, DIFFICULTY IN UNLOADING THE LOADING UNIT MAY BE EXPERIENCED, AND MAY PREVENT FURTHER LOADING FROM OCCURRING. THE INSTRUCTIONS FOR USE (IFU) STATE THAT TO REMOVE THE SINGLE USE LOADING UNIT (SULU), SEPARATE THE INSTRUMENT HALVES. HOLDING THE CARTRIDGE-HALF OF THE INSTRUMENT, GRASP THE PROXIMAL END OF THE SINGLE USE LOADING UNIT (SULU) TABS AND PULL UP AND OUT TO REMOVE THE SINGLE USE LOADING UNIT (SULU) FROM THE INSTRUMENT. TO PLACE A NEW SINGLE USE LOADING UNIT (SULU) INTO THE INSTRUMENT, HOLD THE SINGLE USE LOADING UNIT (SULU) BY THE PROXIMAL END TABS AND INSERT INTO THE CARTRIDGE FORK AT A 30 TO 45 DEGREE ANGLE FROM THE DISTAL END DOWN UNTIL THE UNIT SNAPS INTO PLACE. REMOVE SHIPPING WEDGE AFTER SINGLE USE LOADING UNIT (SULU) IS FULLY LOADED. SINGLE USE LOADING UNIT (SULU) WILL ¿FLOAT¿ UP AND DOWN IN FINAL LOADED POSITION. REPLICATION OF THIS CONDITION MAY OCCUR IF THE LOADING UNIT AND KNIFE BLADE WAS APPLIED OVER AN OBSTRUCTION OR THICK TISSUE DURING CLINICAL APPLICATION. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING OPEN BOWEL RESECTION PROCEDURE, THE DEVICE FIRED PARTIALLY. WHILE USING THE STAPLER ON TRANSECTION, THE SLIDING BLADE GOT STUCK HALF WAY DOWN THE LOAD. THE SURGEON HAD TO PULL IT APART AND RESECT THE BOWEL AND RE STAPLE. THERE WAS TISSUE LOSS AND TISSUE DAMAGE. THEY REPLACED A NEW DEVICE AND RE STAPLE TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353151 GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO GIA6038S P7M1426KX 10884523007237

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention