BEUDAMED
    FDA Adverse Event Death Summary report: N

    STRYKER SUSTAINABILITY SOLUTIONS REFURBISHED COVIDIEN IMPACT LIGASURE WITHOUT NA

    MDR report key: 12435275 · Received September 7, 2021

    Report

    Report Number
    MW5103741
    Event Type
    Death
    Date Received
    September 7, 2021
    Report Date
    September 2, 2021
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS
    Product Code
    NUJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A "REFURBISHED" DEVICE, THE "IMPACT LIGASURE" BY COVIDIEN, REFURBISHED BY COMPANY "STRYKER SUSTAINABILITY SOLUTIONS," TO A LESS THAN NEW STATE WITHOUT NANO COATING, "FAILED TO APPROPRIATELY SEAL/LIGATE AND DIVIDE BLOOD VESSELS," RESULTING IN POST OPERATIVE HEMORRHAGE. THE PATIENT PROCEEDED ON TO END ORGAN ISCHEMIA AND MULTI SYSTEM ORGAN FAILURE AND SUCCUMBED TO THIS INSULT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329093 STRYKER SUSTAINABILITY SOLUTIONS REFURBISHED COVIDIEN IMPACT LIGASURE WITHOUT NA ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, R NUJ STRYKER SUSTAINABILITY SOLUTIONS REFURBISHED LIGASURE IMPACT WITH

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| L