BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 6299621 · Received February 3, 2017

    Report

    Report Number
    6299621
    Event Type
    Malfunction
    Date Received
    February 3, 2017
    Date of Event
    January 3, 2017
    Report Date
    January 24, 2017
    Manufacturer
    STRYKER SUSTAINABILITY SOLUTIONS, INC.
    Product Code
    LFL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPROCESSED HAR 36 SHEARS DID NOT WORK WHEN IT WAS FIRED. A SECOND REPROCESSED HAR 36 WAS OPENED TO COMPLETE THE CASE. NO HARM CAME TO THE PATIENT. MANUFACTURER RESPONSE FOR REPROCESSED SHEARS, ACE HARMONIC (PER SITE REPORTER). THE DEVICE WILL BE RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR FAILURE ANALYSIS. PER THEIR REQUEST, THE GENERATOR TYPE AND SOFTWARE VERSION USED IN THIS CASE WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPROCESSED HAR 36 SHEARS DID NOT WORK WHEN IT WAS FIRED. A SECOND REPROCESSED HAR 36 WAS OPENED TO COMPLETE THE CASE. NO HARM CAME TO THE PATIENT. MANUFACTURER RESPONSE FOR REPROCESSED SHEARS, ACE HARMONIC (PER SITE REPORTER): THE DEVICE WILL BE RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS FOR FAILURE ANALYSIS. PER THEIR REQUEST THE GENERATOR TYPE AND SOFTWARE VERSION USED IN THIS CASE WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82832 N/A SCALPEL, ULTRASONIC, REPROCESSED LFL STRYKER SUSTAINABILITY SOLUTIONS, INC. N/A 4273106

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR