BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GIA

    MDR report key: 8963154 · Received September 4, 2019

    Report

    Report Number
    2647580-2019-04441
    Event Type
    Injury
    Date Received
    September 4, 2019
    Date of Event
    August 12, 2019
    Report Date
    December 23, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523007268
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF THREE DEVICES. VISUAL INSPECTION OF ALL THREE INSTRUMENTS NOTED NO ABNORMALITIES. TWO LOADING UNITS WERE RECEIVED. THE FIRST LOADING UNIT WAS RECEIVED FULLY APPLIED AND THE INTERLOCK WAS ENGAGED. THE KNIFE BLADE DISPLAYED NO DAMAGE, HOWEVER CRACKS WERE NOTED ON THE SURFACE OF THE LOADING UNIT. THE SECOND LOADING UNIT WAS RECEIVED WITH A FULL COMPLEMENT OF STAPLES AND THE INTERLOCK WAS ENGAGED WITH NO KNIFE BLADE DAMAGE. THE FIRST LOADING UNIT WAS RESET WITH STAPLES FROM A TEST LOADING UNIT AND THEN LOADED INTO THE RETURNED INSTRUMENT. THE INSTRUMENT AND LOADING UNIT WERE APPLIED TO THE APPROPRIATE TEST MEDIA WITH ACCEPTABLE RESULTS. THE SECOND LOADING UNIT WAS RESET AND THEN LOADED INTO THE RETURNED INSTRUMENT. THE INSTRUMENT AND SECOND LOADING UNIT WERE APPLIED TO THE APPROPRIATE TEST MEDIA WITH ACCEPTABLE RESULTS. A TEST LOADING UNIT WAS LOADED INTO THE THIRD INSTRUMENT FOR FUNCTIONAL TESTING. THE THIRD INSTRUMENT AND TEST LOADING UNIT WERE APPLIED TO THE APPROPRIATE TEST MEDIA WITH ACCEPTABLE RESULTS. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RE LEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION MAY BE DUE TO USE IN TISSUE THICKER THAN INDICATED. THE INSTRUCTIONS FOR USE (IFU) STATES THAT IF THE TISSUE CANNOT COMFORTABLY COMPRESS TO THE MINIMUM REQUIREMENT, THE TISSUE MAY BE TOO THICK OR TOO THIN FOR THE SELECTED STAPLE SIZE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS DUE TO THE PRODUCT NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. ADDITIONALLY, THE INVESTIGATION DETECTED A UNREPORTED CONDITION OF DID NOT LOAD PROPERLY THAT HAS NO RELATIONSHIP TO THE REPORTED CONDITION. REPLICATION OF THE REPORTED CONDITION MAY OCCUR AS A RESULT OF THE ENGAGED SAFETY LOCK DUE TO IMPROPER LOADING OF THE CARTRIDGE. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC EXPLORATORY, MYOMECTOMY AND BOWEL RESECTION PROCEDURE, ONE OF THE THREE DEVICES FIRED WITHOUT ANY STAPLES AND THEY CANNOT DETERMINE WHICH LOT NUMBER IT IS. THERE WAS A TISSUE LOSS AND TISSUE DAMAGE CAUSED BY THE EVENT. A NEW DEVICE WAS USED TO STAPLE THE BLEEDING BOWEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754640 GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO GIA8038S 10884523007268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R