BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 12088750 · Received June 29, 2021

    Report

    Report Number
    1219930-2021-02609
    Event Type
    Malfunction
    Date Received
    June 29, 2021
    Date of Event
    March 15, 2021
    Report Date
    June 29, 2021
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543614
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. NO INFORMATION REGARDING THE SPECIFIC CUSTOMER ISSUE THAT OCCURRED WITH THE DEVICE WAS AVAILABLE. UPON EXAMINATION OF THE SAMPLE, IT WAS FOUND THAT THE DEVICE WAS APPLIED ON OVER INDICATED TISSUE. VISUAL INSPECTION NOTED THE RELOAD WAS FULLY FIRED WITH THE INTERLOCK ENGAGED. THE CLAMPING MECHANISM WAS DEFORMED. STAPLE PUSHERS WERE PARTIALLY FLUSH WITH THE CARTRIDGE. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE ISSUE OF THE PARTIALLY FLUSH STAPLE PUSHERS AND DEFORMED CLAMPING MECHANISM MAY OCCUR UNDER THE FOLLOWING CONDITIONS: FIRST, APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. SECOND, 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 MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. THE INSTRUCTIONS INCLUDED WITH THIS DEVICE PROVIDE THE FOLLOWING GUIDANCE: FAILURE TO COMPLETELY FIRE THE RELOAD WILL RESULT IN AN INCOMPLETE CUT AND/OR INCOMPLETE STAPLE FORMATION, WHICH MAY RESULT IN POOR HEMOSTASIS AND/OR LEAKAGE. ALWAYS INSPECT THE TISSUE THICKNESS AND SELECT AN APPROPRIATE STAPLE SIZE PRIOR TO APPLICATION OF THE ENDO GIA¿ ULTRA UNIVERSAL SHORT, ENDO GIA¿ ULTRA UNIVERSAL OR ENDO GIA¿ ULTRA UNIVERSAL XL STAPLER. OVERLY THICK OR THIN TISSUE MAY RESULT IN UNACCEPTABLE STAPLE FORMATION. WHEN POSITIONING THE STAPLER ON THE APPLICATION SITE, ENSURE THAT NO OBSTRUCTIONS, SUCH AS CLIPS, ARE INCORPORATED INTO THE INSTRUMENT JAWS. FIRING OVER AN OBSTRUCTION MAY RESULT IN INCOMPLETE CUTTING ACTION AND/OR IMPROPERLY FORMED STAPLES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, WHEN FIRING THE THIRD RELOAD DURING THE TRANSECTION OF THE STOMACH, THE STAPLE LINE WAS INCOMPLETE DISTALLY. THE DEVICE STOPPED AND WOULD NOT FIRE PAST THE FIRST 15MM OF THE RELOAD. THE SURGEON THEN RETRACTED THE RELOAD AND USED A ONE BUT THE SAME ISSUE OCCURRED. ANOTHER DEVICE FROM ANOTHER MANUFACTURER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983106 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGTRS60AXT 0294023NH 10884521543614

    Patients

    Seq Age Sex Outcome Treatment
    1