BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APSII CONTROL CONSOLE

    MDR report key: 18703689 · Received February 14, 2024

    Report

    Report Number
    1220246-2024-00959
    Event Type
    Injury
    Date Received
    February 14, 2024
    Date of Event
    November 19, 2020
    Report Date
    February 14, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    HWE
    UDI-DI
    00888867043138
    PMA / PMN Number
    K932699
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. (NO PROBLEM FOUND) THE EVALUATION DID NOT IDENTIFY ANY ISSUES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SHAVER WAS USED DURING SURGERY WHEN PATIENT GOT CARDIAC ARRHYTHMIA. SURGEON STOPPED THE SHAVER. WHEN THE SURGEON USED THE SHAVER AGAIN, THE CARDIAC ARRHYTHMIA OCCURRED AGAIN WITH THE PATIENT. AFTER SECOND USE THE SURGEON WAS FINISHED WITH USAGE OF THE SHAVER AND THEREFORE HE DIDN´T NEED TO CHANGE THE SHAVER. THE PATIENT IS WELL. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. ***UPDATE SWIT 15-DEC-2020: THE ARTHREX SHAVER AR-8330F ONLY INFLUENCED THE ECG DEVICE IN THE DISPLAY OF CONDUCTION. THE PATIENT DID NOT HAVE ANY ARRHYTHMIAS AT ANY TIME. THE SHAVER IN QUESTION WAS REPLACED DURING THE SURGERY. WITH THE REPLACEMENT DEVICE, THERE WAS NO FURTHER CHANGE ON THE ECG MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379979 APSII CONTROL CONSOLE POWERED SURG ORTHOPEDIC INSTR HWE ARTHREX, INC. APSII CONTROL CONSOLE 00888867043138

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other