BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDO GIA

    MDR report key: 8921750 · Received August 22, 2019

    Report

    Report Number
    1219930-2019-04846
    Event Type
    Injury
    Date Received
    August 22, 2019
    Date of Event
    July 17, 2019
    Report Date
    October 14, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884523003215
    PMA / PMN Number
    K111825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE RELOAD WAS FULLY FIRED. MICROSCOPIC EVALUATION NOTED THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. THE CLAMPING MECHANISM WAS DEFORMED. STAPLE PUSHERS WERE FLUSH WITH THE CARTRIDGE. THERE WAS ONE MALFORMED STAPLE LEFT ON THE CARTRIDGE. FUNCTIONALLY THE RELOAD WAS LOADED INTO A POST MARKET VIGILANCE INSTRUMENT, THE INTERLOCK WAS OVERRIDDEN, AND THE RELOAD WAS APPLIED TO TEST MEDIA. TEST MEDIA WAS TRANSECTED. RECORDS FROM EACH MANUFACTURING LOT ARE THOROUGHLY REVIEWED TO ENSURE THAT PRODUCTS ARE RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE DAMAGED KNIFE BLADE MAY OCCUR WHEN AN OBSTACLE HAS BEEN INCORPORATED IN THE JAWS DURING APPLICATION. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT CAUTIONS THE USER; ENSURE THAT NO OBSTRUCTIONS (SUCH AS CLIPS) ARE INCORPORATED IN THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND/OR IMPROPERLY FORMED STAPLES. REPLICATION OF THE DEFORMED CLAMPING MECHANISM AND PARTIALLY FLUSHED STAPLE PUSHERS MAY OCCUR IF: 1. APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 2. APPLICATION WITH AN OBSTACLE INCORPORATED IN THE JAWS. IN ANY OF THESE CIRCUMSTANCES, IT WILL BECOME INCREASINGLY DIFFICULT TO ACTUATE THE FIRING HANDLE AND THE INSTRUMENT RETURN KNOBS WILL BE DIFFICULT TO RETRACT. IN ADDITION, STAPLES MAY NOT FORM PROPERLY AND TISSUE MAY NOT BE FULLY TRANSECTED. THE INFORMATION BOOKLET WHICH ACCOMPANIES EACH PRODUCT SHIPMENT OFFERS THE FOLLOWING IS A WARNING AND PRECAUTION. "1. PREOPERATIVE RADIOTHERAPY MAY RESULT IN CHANGES TO TISSUE. THESE CHANGES MAY, FOR EXAMPLE, CAUSE THE TISSUE THICKNESS TO EXCEED THE INDICATED RANGE THICKNESS FOR THE STAPLE SIZE. CAREFUL CONSIDERATION SHOULD BE GIVEN TO ANY PRE-SURGICAL TREATMENT THE PATIENT MAY HAVE UNDERGONE AND IN CORRESPONDING SELECTION OF STAPLE SIZE. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS FOUND TO BE DUE TO THE DEVICE NOT BEING USED AS INTENDED WHICH CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. NO FURTHER ACTIONS HAVE BEEN DEEMED NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE GASTRECTOMY, ON THE SECOND FIRING, POOR STAPLE FORMATION WAS NOTED AFTER THE KNIFE BLADE PAUSED DURING FIRING SEQUENCE ON STOMACH. THE SURGEON HAD TO OVERSEW THE STAPLE LINE TO CORRECT THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717169 ENDO GIA STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EGIA60AMT P9B1106KY 10884523003215

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention