BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRI-STAPLE 2.0

    MDR report key: 19686828 · Received July 7, 2024

    Report

    Report Number
    1219930-2024-03070
    Event Type
    Malfunction
    Date Received
    July 7, 2024
    Date of Event
    June 6, 2024
    Report Date
    July 7, 2024
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    UDI-DI
    10884521717619
    PMA / PMN Number
    K173270
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCTS: BOX00662V1, BOX APPENDECTOMY KIT 3.5MM BLUE (LOT#:0228861711), EGIAUSTND, EGIAUSTND ENDOGIA ULTRA UNIV STD STAP (LOT#: UNKNOWN), 030419, 030419 ENDO GIAII 30 3.5MM DLU X6 (LOT#: UNKNOWN). 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.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDECTOMY PROCEDURE, THAT THE MANUAL STAPLER WAS NOT ABLE TO SQUEEZE THE HANDLE TO FIRE THE STAPLER. A NEW KIT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151412 TRI-STAPLE 2.0 STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN SIGTRSB45AXT 10884521717619

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown