BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 8704220 · Received June 17, 2019

    Report

    Report Number
    1219930-2019-03515
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 23, 2019
    Report Date
    July 9, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543638
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 STAPLES PROTRUDING FROM THE PROXIMAL END OF THE RELOAD CARTRIDGE. MICROSCOPIC EVALUATION NOTED THAT THE RELOAD HAD DAMAGE TO THE CUTTING EDGE OF THE KNIFE BLADE. THE CLAMPING MECHANISM WAS DEFORMED. FUNCTIONALLY THE RELOAD WAS LOADED INTO A POST MARKET VIGILANCE INSTRUMENT, THE INTERLOCK WAS OVERRIDDEN, AND THE RELOAD WAS APPLIED TO TEST MEDIA. ALL STAPLES WERE PLACED AND TEST MEDIA WAS CLEANLY 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 ANVIL CLAMPING MECHANISM MAY OCCUR IF THE APPLICATION OVER TISSUE THAT IS BEYOND THE RECOMMENDED THICKNESS RANGE. 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 AS A WARNING AND PRECAUTION. 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 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. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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 A THORACIC PROCEDURE, THE RELOAD WAS CONNECTED WITH THE HANDLE AND WAS USED. THE JAWS WERE ABLE TO OPEN AND CLOSE, BUT AFTER THE TISSUE WAS CLAMPED AND GREEN BUTTON WAS PRESSED, THE HANDLE WAS NOT ABLE TO BE SQUEEZED. A NEW PACKAGE OF THE RELOAD WAS OPENED AND WAS CONNECTED WITH THE HANDLE FOR USE, BUT THE SAME ISSUE OCCURRED. A SECOND HANDLE WAS OPENED AND THE SECOND RELOAD WAS CONNECTED WITH IT TO DEAL WITH THE ISSUE, THE DEVICE WAS ABLE TO FIRE WITHOUT PROBLEMS. THE SURGICAL TIME WAS EXTENDED BY LESS THAN THIRTY MINUTES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498525 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGTRS60AMT 8308007NH 10884521543638

    Patients

    Seq Age Sex Outcome Treatment
    1