BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO GIA

    MDR report key: 20878546 · Received December 9, 2024

    Report

    Report Number
    2647580-2024-05049
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 9, 2024
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523003505
    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#P1H0290S) 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

    IT WAS REPORTED THAT DURING A PNEUMATIC MEDIASTINOSCOPIC ESOPHAGECTOMY FOR ESOPHAGEAL CANCER, THE STAPLER DEVICE, IDENTIFIED THAT THE RELOAD, WAS NOT ABLE TO FIRE DURING THE CLOSURE AND DETACHMENT OF THE ESOPHAGUS. THE ISSUE WAS RESOLVED BY REPLACING THE MALFUNCTIONING DEVICE (HANDLE AND RELOAD) WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334545 ENDO GIA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO 030449 P1G0888S 10884523003505

    Patients

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