BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX SUPPORT ARM

    MDR report key: 7137387 · Received December 21, 2017

    Report

    Report Number
    2523190-2017-00151
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Report Date
    November 28, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETED 12/13/2017. THE DEVICE HISTORY RECORD FOR PRODUCT ID 11050 LOT CODE 171 MANUFACTURED ON 3/28/2017 SHOWED NO ABNORMALITIES RELATED TO REPORTED INCIDENT FOUND NOR WERE THERE ANY VARIANCES, MRR¿S OR REWORKS ASSOCIATED WITH EITHER LOT &/OR WORK ORDER NUMBER. EVALUATION VERIFIED CUSTOMER INFORMATION AS VALID. CLAMP DOES NOT BUILD ENOUGH PRESSURE UP. ROOT CAUSE IS MOST LIKELY ACCELERATED WEAR AND TEAR OF PARTS INTERNAL TO CLAMP.

    Description of Event or Problem · 1

    CUSTOMER REPORTS THE SUPPORT ARM MOVES WITH A SLIGHT FORCE WHILE IN LOCKED POSITION. NO HARM DONE. #2 OF 2 RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916581 OMNI-FLEX SUPPORT ARM SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 171

    Patients

    Seq Age Sex Outcome Treatment
    1