BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 7922720 · Received October 1, 2018

    Report

    Report Number
    1219930-2018-05300
    Event Type
    Malfunction
    Date Received
    October 1, 2018
    Date of Event
    August 27, 2018
    Report Date
    March 4, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543744
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. VISUAL INSPECTION OF THE RETURNED PRODUCT NOTED THAT THE RELOAD WAS PRE-FIRED. THERE WERE NO STAPLES PROTRUDING FROM PROXIMAL STAPLE CARTRIDGE CHANNEL. MICROSCOPIC EVALUATION NOTED THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. FUNCTIONALLY, THE RELOAD WAS LOADED INTO A POST MARKET VIGILANCE INSTRUMENT, THE INTERLOCK WAS OVERRIDDEN, AND THE RELOAD WAS APPLIED TO TEST MEDIA. ALL REMAINING STAPLES WERE PLACED, AND TEST MEDIA WAS CLEANLY TRANSECTED. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS PRODUCT WAS 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 PRE-FIRE CONDITION WITH INTERLOCK ENGAGEMENT MAY OCCUR IF THE INSTRUMENT FIRING HANDLE HAD BEEN PARTIALLY COMPRESSED AND RELEASED AFTER PRESSING THE GREEN FIRING BUTTON. IN THIS SITUATION, THE SAFETY INTERLOCK FEATURE WILL ENGAGE AND PREVENT THE RELOAD FROM FIRING A SECOND TIME BY CEASING THE PLACEMENT OF STAPLES AND TISSUE TRANSECTION AND PREVENT PATIENT HARM. THE ROOT CAUSE OF THE OBSERVED DAMAGE WAS MISUSE OF THE PRODUCT 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 · 0

    ACCORDING TO THE REPORTER, AFTER DISSECTION OF THE LOBAR ARTERY IN A VIDEO-ASSISTED THORACOSCOPIC SURGERY, THE RELOAD DID NOT WORK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT WAS UNABLE TO SQUEEZE THE HANDLE. HOWEVER, THE STAPLER WORKED WITH OTHER RELOADS. THE SURGEON CHANGED THE STAPLER AND THE STAPLING WORKED. NO INJURY.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, AFTER DISSECTION OF THE LOBAR ARTERY IN A VIDEO-ASSISTED THORACOSCOPIC SURGERY, THE RELOAD DID NOT WORK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT WAS UNABLE TO SQUEEZE THE HANDLE. HOWEVER, THE STAPLER WORKED WITH OTHER RELOADS. THE SURGEON CHANGED THE STAPLER AND THE STAPLING WORKED. NO INJURY.

    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, AFTER DISSECTION OF THE LOBAR ARTERY IN A PROCEDURE, THE RELOAD DID NOT WORK. THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT WAS UNABLE TO SQUEEZE THE HANDLE. HOWEVER, THE STAPLER WORKED WITH OTHER RELOADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765575 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIG30CTAVM N8E0495X 10884521543744

    Patients

    Seq Age Sex Outcome Treatment
    1