BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STANDARD WISHBONE ASSEMBLY

    MDR report key: 8953941 · Received September 2, 2019

    Report

    Report Number
    3004608878-2019-00649
    Event Type
    Malfunction
    Date Received
    September 2, 2019
    Report Date
    August 14, 2019
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS PART OF SERVICE AND REPAIR REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA (B)(4). THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR SERVICE AND REPAIR. THE UNIT WAS CLEANED PER PROTOCOL. IT WAS NOTED UPON INSPECTION THAT THE RETURNED UNIT DID NOT MEET ALL SPECIFIC FUNCTIONAL TESTS. THE UNIT RECEIVED IS LOOSE FROM ROUTINE USE. THE UNIT WILL NEED TO BE ADJUSTED AND LUBRICATED. GENERAL MAINTENANCE IS NEEDED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED FAILURE.

    Description of Event or Problem · 1

    THE USER FACILITY RETURNED THE 4020 STANDARD WISHBONE ASSEMBLY FOR SERVICE AND REPAIR BECAUSE THE UNIT WAS LOOSE FROM ROUTINE USE..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747270 STANDARD WISHBONE ASSEMBLY SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1