BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX SUPPORT ARM

    MDR report key: 8938132 · Received August 27, 2019

    Report

    Report Number
    3004608878-2019-00280
    Event Type
    Malfunction
    Date Received
    August 27, 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 HEALTH CARE PROFESSIONAL

    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. IT WAS NOTED UPON INSPECTION THAT THE RETURNED UNIT DID NOT MEET ALL SPECIFIC FUNCTIONAL TESTS. THE UNIT WAS RECEIVED WITH (2) 10269 ARMS AND (2) 10270 ARMS WHICH WILL BE RETURNED TO THE CUSTOMER WITH THE REPAIRED UNIT. THE RECEIVED UNIT WAS DETERMINED TO BE LOOSE DUE TO ROUTINE USE. THE UNIT RECEIVED ADJUSTMENT ASSOCIATED WITH PERIODIC MAINTENANCE. A REVIEW OF THE DEVICE'S 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 11050 OMNI-FLEX SUPPORT ARM FOR SERVICE AND REPAIR BECAUSE THE UNIT WAS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732023 OMNI-FLEX SUPPORT ARM SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1