BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECIPROC BLUE FILES, 6X, STERILE

    MDR report key: 14279762 · Received May 4, 2022

    Report

    Report Number
    9611053-2022-00540
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Report Date
    May 17, 2022
    Manufacturer
    VDW GMBH
    Product Code
    EKS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE HAS BEEN A PREVIOUS REPORT RECEIVED WITH A SIMILAR DEVICE WHERE THIS MALFUNCTION RESULTED IN A SERIOUS INJURY. THEREFORE, IT MUST BE PRESUMED THAT RECURRENCE OF THIS MALFUNCTION COULD POSSIBLY CAUSE OR CONTRIBUTE TO A SERIOUS INJURY OR REQUIRE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SUCH. AS SUCH, THIS EVENT IS REPORTABLE PER 21CFR PART 803. THE DEVICE IS AVAILABLE FOR EVALUATION, THOUGH HAS NOT BEEN RETURNED AS OF THIS REPORT. EVALUATION RESULTS WILL BE SUBMITTED AS THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN THE DEVICE FOR EVALUATION. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT PROVIDED FOR RETAINED-PRODUCT TESTING AND/OR DHR REVIEW. ALL COMPLAINTS ARE MONITORED THROUGH THE MONTHLY PRODUCT SURVEILLANCE COMMITTEE AND A CORRECTIVE ACTION COULD BE DETERMINED BY THE COMMITTEE.

    Description of Event or Problem · 0

    IN THIS EVENT IT HAS BEEN REPORTED THAT A RECIPROC BLUE FILES, 6X, STERILE FILE BROKE DURING USE. THE OUTCOME OF THE EVENT IS UNKNOWN AS OF THIS MDR EVALUATION. FURTHER INFORMATION AND PRODUCT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2308774 RECIPROC BLUE FILES, 6X, STERILE FILE, PULP CANAL, ENDODONTIC EKS VDW GMBH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown