BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 18813502 · Received February 29, 2024

    Report

    Report Number
    1219930-2024-00987
    Event Type
    Malfunction
    Date Received
    February 29, 2024
    Date of Event
    February 9, 2024
    Report Date
    September 10, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521543720
    PMA / PMN Number
    K160176
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. FUNCTIONAL TESTING FOUND THAT THE RELOAD JAWS WERE FORCED OPEN. STAPLES, TISSUE, AND BROKEN PIECES OF SURGICAL CLIPS FELL FROM THE RELOAD. A SURGICAL CLIP WAS STUCK IN THE TRACK OF THE RELOAD ANVIL. IT WAS REPORTED THAT THE INSTRUMENT WAS LOCKED ON TISSUE AND WAS DIFFICULT TO UNLOAD. THE REPORTED ISSUES WERE CONFIRMED. THE PRODUCT ANALYSIS NOTED EVIDENCE THAT THE DEVICE WAS NOT USED AS INTENDED. THE EVALUATION DETECTED UNREPORTED CONDITIONS: OF EXCESSIVE TORQUE AND INTERLOCK NOT ENGAGING. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THIS ISSUE CAN OCCUR IF EXCESSIVE TORQUE IS APPLIED TO THE MANUAL RETRACT TOOL. 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: 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE, (SN: UNKNOWN) SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE, (SN: UNKNOWN) SIGADAPTSTND, SIG POWER SIGADAPTSTND LINEAR ADAPTER, (SN: UNKNOWN) SIGMRET, SIG POWER SIGMRET MANUAL RETRACT TOOL, (SN: UNKNOWN) 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC THORASCOPIC WEDGE RESECTION PROCEDURE, AFTER STAPLING A LARGE VESSEL OF THE LUNG BEING, THE SURGEON TRIED OPENING THE DEVICE BUT THE JAWS DID NOT OPEN; THE BLADE GOT STUCK WHILE COMING BACK. A NEW HANDLE AND SHELL WERE USED, BUT IT STILL DID NOT WORK. A MANUAL ADAPTER (RETRACTOR) WAS ALSO USE TO ATTEMPT OPEN THE JAWS BUT THE ISSUE REMAINED THE SAME. THE SURGEON THEN CLIPPED THE SIDES OF THE RELOAD AND CUT ON BOTH SIDES OF THE JAWS TO REMOVE THE DEVICE. ONCE TAKEN OUT AND EXAMINED, IT WAS FOUND OUT THAT THE STAPLER HAD STAPLED OVER A CLIP AND GOT STUCK WHILE TRYING TO RETRACT THE DEVICE. THE DEVICE WAS ALSO DIFFICULT TO UNLOAD. THIS LED TO ABOUT 30 MINUTES EXTENDED SURGICAL TIME AND TISSUE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323150 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIG45CTAVM N3K2742Y 10884521543720

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown