BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORCEPS MCO781 95MM INSERTOR T TUBE

    MDR report key: 11820883 · Received May 13, 2021

    Report

    Report Number
    2523190-2021-00099
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Report Date
    May 13, 2021
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    KAE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD (DHR) - THE DHR WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE FORCEPS MC0781 WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - THE EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY THE COMPLAINT AS VALID. THE RECEIVED DEVICE IS COMPLAINT WITH THE SPECIFICATIONS. IT WORKS PROPERLY WITH A T TUBE 12MM LONG. ROOT CAUSE - THE INVESTIGATION DID NOT HIGHLIGHT ANY DEFECT, THIS COMPLAINT IS NOT RELATED TO THE RECEIVED DEVICE. THIS ISSUE IS DUE TO THE USE OF A T TUBE NOT COMPATIBLE (6MM LONG).

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT DURING TESTING, THE FORCEPS MCO781 WAS UNABLE TO PUSH THE T TUBE TO THE EAR. THE T TUBE ADAPTED TO THE MCO781, ENTERED IN THE EAR HOLE, BUT THE INSERTER MCO781 DID NOT RELEASE IT. THERE WAS NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719862 FORCEPS MCO781 95MM INSERTOR T TUBE PFM11 KAE INTEGRA MICROFRANCE S.A.S. 5372252

    Patients

    Seq Age Sex Outcome Treatment
    1