BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EMAX 2 PLUS MOTOR

    MDR report key: 14346489 · Received May 10, 2022

    Report

    Report Number
    1045834-2022-00559
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    May 2, 2022
    Manufacturer
    THE ANSPACH EFFORT LLC
    Product Code
    GEY
    UDI-DI
    00845384002055
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL NARRATIVE: AS OF THIS DATE, THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED AND/OR DUPLICATED. UDI ¿ (B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A SUPPLEMENTAL MEDWATCH REPORT WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: THE ACTUAL DEVICE WAS RETURNED FOR EVALUATION. THE MOTOR DEVICE WAS EVALUATED AND THE REPORTED CONDITION THAT THE DEVICE WAS NOT WORKING, AND THE CONSOLE INDICATOR WAS DISPLAYING AN E6 ERROR CODE WAS NOT CONFIRMED. THEREFORE, AN ASSIGNABLE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, DURING EVALUATION IT WAS OBSERVED THAT THE DEVICE HAD FOREIGN SUBSTANCE/DEBRIS/CLEANING/STERILIZATION. THE ASSIGNABLE ROOT CAUSE OF THIS CONDITION WAS DETERMINED TO BE TRACED TO MAINTENANCE, WHICH IS IMPROPER MAINTENANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PRE-SURGERY TESTING IT WAS OBSERVED THAT THE MOTOR DEVICE WAS NOT WORKING. IT WAS REPORTED THAT THE CONSOLE INDICATOR OF THE DEVICE WAS DISPLAYING AN E6 ERROR CODE (OVERHEAT WARNING). THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233317 EMAX 2 PLUS MOTOR MOTOR, SURGICAL INSTRUMENT, AC-POWERED GEY THE ANSPACH EFFORT LLC EMAX2PLUS 00845384002055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown