BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC/COVIDIEN SURGICAL STAPLERS

    MDR report key: 20639594 · Received November 7, 2024

    Report

    Report Number
    MW5162321
    Event Type
    Other
    Date Received
    November 7, 2024
    Date of Event
    January 2, 2019
    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

    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 LIFE THREATENING INJURIES (LEAKING ANASTOMOSIS WITHIN 3 DAYS OF SURGERY, INTENSIVE CARE TREATMENT, SEPSIS, MECHANICAL VENTILATION, EXTENDED HOSPITALIZATION), AND INTERVENTIONAL SURGERIES TO CORRECT ANY INJURIES. REF REPORTS: MW5162319, MW5162320, MW5162322, MW5162323.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1540473 MEDTRONIC/COVIDIEN SURGICAL STAPLERS STAPLER, SURGICAL GAG MEDTRONIC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown