BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 19176411 · Received April 24, 2024

    Report

    Report Number
    2647580-2024-01858
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    April 1, 2024
    Report Date
    April 24, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523002997
    PMA / PMN Number
    K111825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT PRODUCT: 030425, 030425 ENDO GIAII 45 2.5MM DLU X6 (LOT#P1M0586S); EGIAUSTND, EGIAUSTND ENDOGIA ULTRA UNIV STD STAP (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 VIDEO-ASSISTED THORACOSCOPIC SURGERY (VATS) WEDGE RESECTION PROCEDURE, ON TWO RELOADS, THE SURGEON WAS ABLE TO PRESS THE GREEN BUTTON, BUT THE HANDLE COULD NOT BE SQUEEZED. THE DEVICES DID NOT FIRE. TO RESOLVE THE ISSUE, ONLY THE RELOAD WAS REPLACED. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1616695 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 030425 P1M0586S 10884523002997

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PLEASE SEE NOTE ON H11