BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 17402579 · Received July 27, 2023

    Report

    Report Number
    1219930-2023-03192
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    July 11, 2023
    Report Date
    July 26, 2023
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. THE EVALUATION FOUND NO POTENTIALLY CONTRIBUTING FACTORS, AND THE SAMPLE MET ALL RELATED SPECIFICATIONS. IT WAS REPORTED THAT THE JAWS OF THE DEVICE REMAIN CLOSED ON TISSUE, THE DEVICE DID NOT FIRE, THE ARTICULATING DEVICE EXPERIENCED DIFFICULTY IN STRAIGHTENING OR ALIGNING DISTAL END TO THE NEUTRAL POSITION AND THE JAWS OF THE DEVICE ROTATED UNEXPECTEDLY. THE REPORTED ISSUES COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE IDENTIFIED BECAUSE NO RELATED PROBLEM WAS DETECTED WITH THE DEVICE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. D10 CONCOMITANT PRODUCT: SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE (SERIAL# (B)(6); SIGADAPTSTND, SIG POWER SIGADAPTSTND LINEAR ADAPTER (SERIAL# (B)(6); SIGPSHELL, SIG POWER SIGPSHELL CONTROL SHELL (LOT#UNKNOWN); SIGPHANDLE, SIG POWER SIGPHANDLE HANDLE (SERIAL# (B)(6). 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 ROBOT-ASSISTED ESOPHAGECTOMY PROCEDURE, AT THE TIME OF CUTTING THE AZYGOS VEIN, THE BLOOD VESSEL WAS CLAMPED, THE GREEN BUTTON WAS PRESSED DOWN, AND THE LOWER BUTTON OF THE ROTATION WAS DOUBLE CLICKED TO SET THE DEVICE INTO SLOW MODE. THE DEVICE WOULD NOT FIRE. THEN, EVEN THOUGH NO BUTTON WAS BEING PRESSED, THE DEVICE ROTATED ON ITS OWN. THE USER HOLDING THE HANDLE TWISTED HIS HAND TO CONTROL THE DEVICE AND RELAXED THE TENSION ON THE BLOOD VESSEL TO PREVENT VASCULAR DAMAGE. THE SURGEON THEN ATTEMPTED OPENING THE JAWS, BUT IT DID NOT RESPOND. A MANUAL RETRACTOR WAS USED TO OPEN, STRAIGHTEN, AND REMOVE THE DEVICE. THE ADAPTER WAS THEN CONNECTED TO ANOTHER HANDLE, BUT AN ADAPTER YELLOW ERROR MESSAGE WAS DISPLAYED. A COMPETITOR'S DEVICE WAS USED TO RESOLVE THE ISSUE. THE SECOND HANDLE WAS TESTED AND WORKED AFTER REBOOT. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637671 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIG30CTAVM 10884521543744

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PLEASE SEE NOTE ON H10