BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNI-FLEX STERILE FIELD POST

    MDR report key: 6952307 · Received October 16, 2017

    Report

    Report Number
    2125289-2017-00015
    Event Type
    Malfunction
    Date Received
    October 16, 2017
    Report Date
    September 21, 2017
    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

    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.

    Additional Manufacturer Narrative · 1

    ON 10/20/2017 INTEGRA INVESTIGATION COMPLETED. MANUFACTURE DATE UNKNOWN. METHOD: FAILURE ANALYSIS, DEVICE HISTORY EVALUATION. RESULTS: FAILURE ANALYSIS - COMPLAINT CONFIRMED. UNIT RECEIVED HAS A BENT HANDLE ON THE POST CLAMP SUBASSEMBLY ALLOWING THE CLAMP TO ROTATE WHILE IN THE LOCKED POSITION. GENERAL MAINTENANCE NEEDED. DEVICE HISTORY EVALUATION - THE DEVICES MANUFACTURED PASSED ALL REQUIRED INSPECTION POINTS WITH NO ASSOCIATED MRR¿S, VARIANCES OR REWORK. NO SERVICE HISTORY IS ON FILE FOR THIS DEVICE. DEVICE IS 100% TESTED PRIOR TO FINAL ACCEPTANCE. CONCLUSION: FAILURE ANALYSIS TO IDENTIFY ROOT CAUSE CONFIRMED COMPLAINT EVENT. THE MOSTLY LIKELY REASON FOR COMPLAINT EVENT IS ACCELERATED WEAR AND TEAR ON DEVICE. VISUAL INDICATIONS INDICATE HANDLE HAD BEEN OVER THROWN, BENDING CAM AND HANDLE.

    Description of Event or Problem · 1

    DEALER RECEIVED THE COMPLAINT FROM CUSTOMER: ¿CLAMP PERFORMANCE FOR ATTACHING ARM DECLINED¿ . ON 10/2/2017 THE DEALER EXPLAINED THE COMPLAINT : " WE INSERTED THE ARM AND LOCKED IT COMPLETELY, CLAMP WAS NOT FIXED TO THE SHAFT, ROTATING VERY EASILY EVEN IF WEAK FORCE WAS APPLIED¿. ON 10/10/2017 DEALER REPORTS "THE ISSUE WAS FOUND DURING CHECKING FOR SETUP JUST BEFORE THE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730814 OMNI-FLEX STERILE FIELD POST SURGICAL RETRACTOR FFO INTEGRA LIFESCIENCES CORPORATION OH/USA

    Patients

    Seq Age Sex Outcome Treatment
    1