BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE MCO7A-1 DIA 2.5/2.2MM N1/2

    MDR report key: 12445555 · Received September 9, 2021

    Report

    Report Number
    2523190-2021-00200
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    October 5, 2020
    Report Date
    October 22, 2021
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JYG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D1, D2A, D3, D4, D9, G3, G9, H2, H3, H6, H10. THE CURETTE (MCO7A-1) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS: EVALUATION OF THE CURETTE VERIFIED THE COMPLAINT REPORTED BY THE CUSTOMER AS VALID. ONE SIDE OF THE DEVICE WAS BROKEN, AND THE OTHER WAS BENT. THERE IS NO BATCH NUMBER ON THE DEVICE THAT IT SUGGESTS IT IS A VERY OLD DEVICE. THERE IS AN ETCHING "1995" WHICH MAY CORRESPOND TO THE DATE OF PURCHASING BY THE CUSTOMER. THERE IS NO SERVICING ETCHING. ROOT CAUSE: CONSIDERING THE DATE OF MANUFACTURE OF THE DEVICE, AROUND 1995, THE REPORTED EVENT IS DUE TO A NORMAL WEAR OF THE DEVICE.

    Description of Event or Problem · 0

    N/A.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT DURING EAR SURGERY, THE INSTRUMENT (MCO7A) BROKE INTO TWO PARTS. THE PARTS WERE RETRIEVED BY THE SURGEON. AN UNSPECIFIED INCREASE IN SURGERY TIME WAS REPORTED; HOWEVER, NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1342598 CURETTE MCO7A-1 DIA 2.5/2.2MM N1/2 PFM11 JYG INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1