BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURETTE MCO7A-3 DIA 1.9/1.5MM N3/4

    MDR report key: 11699289 · Received April 21, 2021

    Report

    Report Number
    2523190-2021-00077
    Event Type
    Malfunction
    Date Received
    April 21, 2021
    Date of Event
    March 15, 2021
    Report Date
    April 21, 2021
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JYG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CURETTE (MCO7A-3) WAS RECEIVED FOR EVALUATION: DEVICE HISTORY RECORD (DHR) - NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WAS OBSERVED. FAILURE ANALYSIS - THE ACTIVE PART OF THE DEVICE IS BROKEN. THE FRAGMENT WAS NOT RETURNED. THERE IS NO MATERIAL DEFECT AT THE BREAKAGE AREA AND NO MANUFACTURING DEFECT. ROOT CAUSE - THIS ISSUE IS PROBABLY DUE TO AN IMPROPER HANDLING OF THE DEVICE DURING THE USE OR TO A DAMAGE OF THE DEVICE DURING THE CLEANING PRIOR TO THE SURGERY AND NOT DETECTED BY THE CUSTOMER.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT THE CURETTE (PRODUCT ID MCO7A-3) BROKE DURING FIRST USE. THE BROKEN PART WAS STILL ATTACHED TO THE MAIN PART OF THE INSTRUMENT. NO PATIENT INJURED OR DEATH ALLEGED, AND THE EVENT DID NOT LEAD TO AN INCREASE OF SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596606 CURETTE MCO7A-3 DIA 1.9/1.5MM N3/4 PFM11 JYG INTEGRA MICROFRANCE S.A.S.

    Patients

    Seq Age Sex Outcome Treatment
    1