BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS

    MDR report key: 8039519 · Received November 5, 2018

    Report

    Report Number
    9610612-2018-00484
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    September 21, 2018
    Report Date
    December 17, 2018
    Manufacturer
    AESCULAP AG
    Product Code
    HBC
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    WE DID RECEIVE THE PRODUCT IN DECONTAMINATED CONDITION FOR INVESTIGATION. OPTICALLY, THE MOTOR CABLE IS IN GOOD CONDITION. THE MOTOR CABLE HAS BEEN CHECKED VISUALLY. A FUNCTIONALLY TEST BY R&D REVEALED NO DEVIATION. THE LEVER OPERATES AS INTENDED. ON THE HEADPIECE CONNECTION SIDE, STAINING COULD BE DETECTED ON SEVERAL LOCATIONS. IN THE COURSE OF THE INVESTIGATION, IT COULD BE DETECTED THAT THE THREAD OF THE SLEEVE CAN BE SEEN. THIS IS ONLY AN OPTICAL FLAW WHICH DOES NOT STAND IN CORRELATION WITH THE LEVER ISSUE. THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED AND FOUND TO BE ACCORDING TO THE SPECIFICATION, VALID AT THE TIME OF PRODUCTION. NO FURTHER COMPLIANT REGISTER AGAINST THE SAME LOT NUMBER. THE FAILURE IS USAGE RELATED. ON THE BASIS OF THE PROVIDED INFORMATION AS WELL AS THE INTERNAL INVESTIGATION, THE BONE WAX CAME IN CONTACT WITH THE LEVER DURING THE SURGERY. THIS LED TO THE MENTIONED FAILURE PATTERN. NO PRODUCT RELATED FAILURE. THERE IS NO CAPA NECESSARY.

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING. DATE REPORTABILITY CHANGE DUE TO RE-ASSESSMENT. SIMILAR DEVICE ELAN 4 ELECTRIC MOTOR SYSTEM: K152960. PENDING FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL TO THE COMPANY SALES REPRESENTATIVE "THE LEVER WAS NOT RELEASED, NOT BACK TO THE NORMAL POSITION DURING USE. THE PRODUCT WAS NEWLY PURCHASED AND A TEST WAS PERFORMED THE DAY BEFORE SURGERY, AND CONFIRMED IT WORKED PROPERLY. THE FIRST DAY USED, THE PRODUCT WORKED WITHOUT PROBLEMS FOR THE FIRST SURGERY, HOWEVER, IN THE SECOND SURGERY, THE LEVER WOULD NOT RELEASE. THE SALES REP CHECKED THE PRODUCT AFTER THE SURGERY AND CONFIRMED THE LEVER WAS NOT RELEASING SMOOTHLY OR NEVER RELEASED. BY CHECKING THE MOTION OF THE LEVER REPEATEDLY, THE FAILURE WAS GETTING BETTER BUT STILL NOT PROPERLY RELEASING. THE SURGICAL PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO HARM TO THE PATIENT REPORTED. THIS INCIDENT DID NOT CAUSE ANY DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878937 ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS HIGH SPEED POWER SYSTEMS HBC AESCULAP AG GA804 52422024

    Patients

    Seq Age Sex Outcome Treatment
    1