BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM 1362275 UNIVERSAL FLEXIBLE

    MDR report key: 12824186 · Received November 16, 2021

    Report

    Report Number
    3014334038-2021-00226
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 8, 2021
    Report Date
    March 11, 2022
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    FXG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE UNIVERSAL FLEXIBLE ARM (1362275) WAS RETURNED FOR EVALUATION: THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES RELATED TO THE REPORTED FAILURE WERE OBSERVED. FAILURE ANALYSIS: BASED ON VISUAL/SUPPLIER EVALUATION, THE UNIVERSAL FLEXIBLE ARM WAS RETURNED IN USED CONDITION WITH THE TIP BROKEN OFF. THE COMPLAINT REPORTED BY THE CUSTOMER WAS CONFIRMED. ROOT CAUSE ANALYSIS: SUPPLIER INVESTIGATION IDENTIFIED THAT THIS ISSUE MAY BE THE RESULT OF EXCESS TIGHTENING AND INSUFFICIENT SOLDERING AT THE END OF THE ARM. SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED FOR THIS ISSUE. IN ADDITION, A VOLUNTARY RECALL OF THIS PRODUCT WAS INITIATED BY THE COMPANY.

    Description of Event or Problem · 0

    A FACILITY REPORTED THAT THE UNIVERSAL SPECULUM HOLDER/UNIVERSAL FLEXIBLE ARM (1362275) CAME APART WHEN THE SURGEON MOUNTED IT TO THE TABLE. THE ISSUE OCCURRED PRIOR TO A STAPEDECTOMY PROCEDURE. AS A RESULT, THERE WAS A 30-MINUTE DELAY OF THE PROCEDURE. HOWEVER, NO PATIENT INJURY OR DEATH OCCURRED.

    Description of Event or Problem · 0

    N/A

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723351 ARM 1362275 UNIVERSAL FLEXIBLE PFM11 FXG INTEGRA LIFESCIENCES MANSFIELD AC2109

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown