BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX STERILE FIELD POST

    MDR report key: 7115207 · Received December 13, 2017

    Report

    Report Number
    2125289-2017-00017
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    September 28, 2017
    Report Date
    November 20, 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

    INVESTIGATION COMPLETED 01/02/2018. DEVICE HISTORY RECORD REVIEWED FOR PRODUCT ID: 10244, LOT CODE: 167 WAS MANUFACTURED ON 25AUG2017 WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. THE HANDLE IS BENT ON THE POST CLAMP SUBASSEMBLY ALLOWING THE CLAMP TO ROTATE WHILE IN THE LOCKED POSITION. GENERAL MAINTENANCE NEEDED. PREVIOUS REPAIRS DOCUMENTED ON RETURNED UNIT. FAILURE ANALYSIS TO IDENTIFY ROOT CAUSE CONFIRMED COMPLAINT EVENT. MOST LIKELY REASON IS WEAR AND TEAR.

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS BOTTOM PART OF OMNI POST (CLAMP) DOESN¿T TIGHTEN DOWN TO BED RAIL. EXHIBITS MOVEMENT. ON (B)(6) 2017 CUSTOMER CAN NOT PROVIDE FURTHER INFORMATION, ANSWERS FROM OR NOT FORTHCOMING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    892542 OMNI-FLEX STERILE FIELD POST SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA 167

    Patients

    Seq Age Sex Outcome Treatment
    1