BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC/COVIDIEN SURGICAL STAPLERS

    MDR report key: 20639597 · Received November 7, 2024

    Report

    Report Number
    MW5162322
    Event Type
    Other
    Date Received
    November 7, 2024
    Date of Event
    October 3, 2022
    Report Date
    November 5, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GAG
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE SURGICAL STAPLER WAS DEFECTIVELY MANUFACTURED / DESIGNED. MS. (B)(6). SUFFERED SERIOUS INJURY REQUIRING SURGICAL INTERVENTION, USING AN FDA GRADING OF INJURIES RESULTING FROM USE OF A MALFUNCTIONING MEDTRONIC/COVIDIEN SURGICAL STAPLER. HER INJURIES INCLUDE ANASTOMOTIC LEAK WITHIN 4 DAYS OF SURGERY CAUSING LIFE THREATENING INJURIES (INTENSIVE CARE TREATMENT, SEPSIS, TRANSFUSION, RESECTION OF ILEOSTOMY CLOSURE AND ILEOSTOMY, EXTENDED HOSPITALIZATION), AND SUBSEQUENT SURGERIES TO CORRECT ANY INJURIES. REF REPORTS: MW5162319, MW5162320, MW5162321, MW5162323.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540474 MEDTRONIC/COVIDIEN SURGICAL STAPLERS STAPLER, SURGICAL GAG MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown