BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX STERILE FIELD POST

    MDR report key: 7002336 · Received November 5, 2017

    Report

    Report Number
    2125289-2017-00016
    Event Type
    Malfunction
    Date Received
    November 5, 2017
    Date of Event
    September 28, 2017
    Report Date
    October 13, 2017
    Manufacturer
    INTEGRA LIFESCIENCES CORPORATION OH/USA
    Product Code
    FFO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/23/2017 INTEGRA INVESTIGATION COMPLETED. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION RESULTS: FAILURE ANALYSIS - COMPLAINT CONFIRMED. UNIT RECEIVED DOES NOT PROPERLY ATTACH TO THE RAIL. ALL OTHER FUNCTIONAL TESTS PASSED. GENERAL MAINTENANCE NEEDED. DEVICE HISTORY EVALUATION - A TOTAL OF (B)(4) WERE PRODUCED OF THIS LOT IN 2016. THE DEVICES MANUFACTURED DURING THIS PERIOD PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK, SEE BELOW. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. CONCLUSION - MOST LIKELY REASON FOR COMPLAINT EVENT IS WEAR AND TEAR.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS THE BOTTOM PART OF OMNI POST (CLAMP) DOESN'T TIGHTEN DOWN TO BED RAIL. EXHIBITS MOVEMENT. ON (B)(6) 2017 CUSTOMER REPORTS "A WHIPPLE PROCEDURE WAS BEING PERFORMED. ATTACHED THE POST TO THE BED AND WHEN ATTACHING THE BAR THAT ATTACHES TO THE OMNI POST AND LOCKING INTO PLACE THE WHOLE ARM WOULD MOVE. NO HARM TO PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781581 OMNI-FLEX STERILE FIELD POST SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 169

    Patients

    Seq Age Sex Outcome Treatment
    1