BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KNIFE MCO5D MICROFRANCE SUCTION RND 2MM

    MDR report key: 8252842 · Received January 16, 2019

    Report

    Report Number
    2523190-2019-00003
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Date of Event
    December 6, 2018
    Report Date
    December 26, 2018
    Manufacturer
    INTEGRA MICROFRANCE S.A.S.
    Product Code
    JYO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD (DHR ) SHOWS NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT. THEREFORE, AN INVESTIGATION CAN NOT BE CARRIED OUT BECAUSE THE INSTRUMENT OF THE COMPLAINT HAS NOT BEEN RETURNED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10, G4, G7, H2, H3, H6, H10. THE DEVICE WAS RETURNED FOR EVALUATION. THE DEVICE WAS BROKEN AT THE WELDING AREA. THE TUBE WITH THE ACTIVE PART WAS SLIGHTLY BENT. THE CLEANING WIRE WAS MISSING. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO ANOMALIES THAT COULD BE ASSOCIATED WITH THE COMPLAINT WERE OBSERVED. THE REPORTED COMPLAINT WAS CONFIRMED. THE BREAKAGE WAS PROPABLY DUE TO A BAD HANDLING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A DOCTOR REPORTED THAT ON (B)(6) 2018 WHILE ADJUSTING THE SHAFT OF THE MCO5D KNIFE MICROFRANCE SUCTION RND, DURING FIRST TIME USE, THERE WAS A FRACTURE IN THE CONNECTION BETWEEN TWO PARTS. A (B)(6) MALE PATIENT WAS PREPPED FOR AN UNSPECIFIED SURGERY. THERE WAS NO PATIENT CONTACT, PATIENT INJURY/DEATH ALLEGED. THERE WAS APPROXIMATELY 0.5 HOUR (30 MINUTES) OF DELAY IN SURGERY. ADDITIONAL INFORMATION RECEIVED ON 28DEC2018 STATED THAT THE SURGICAL DELAY DID NOT CAUSE AN IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44846 KNIFE MCO5D MICROFRANCE SUCTION RND 2MM PFM11 JYO INTEGRA MICROFRANCE S.A.S. 2789466

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR