BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELAN 4 AIR MOTOR HOSE 3M W/HAND CONTROL

    MDR report key: 9179962 · Received October 11, 2019

    Report

    Report Number
    9610612-2019-00666
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    August 26, 2019
    Report Date
    December 31, 2019
    Manufacturer
    AESCULAP AG
    Product Code
    HBB
    PMA / PMN Number
    K172907
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A PRELIMINARY INVESTIGATION HAD BEEN PREPARED ON 22NOV2019 AS THE PRODUCT WAS FORWARDED TO AESCULAP TECHNICAL SERVICES (ATS) AND THE MANUFACTURER FOR EVALUATION. INTERNAL NOTIFICATION NUMBER: 400444309 DEVICE. REFERENCE CODE GA706R. DEVICE NAME ELAN 4 AIR MOTOR HOSE 3M W/HAND CONTROL. SERIAL NUMBER (B)(4). BATCH NUMBER 52517443. UDI DEVICE IDENTIFIER N/A. UDI PRODUCTION IDENTIFIER N/A. BASIC UDI-DI N/A. UNIT OF USE UDI-DI N/A. MANUFACTURING DATE 13.06.2019. WE DID RECEIVE THE DEVICE FOR INVESTIGATION. IT WAS FORWARDED TO THE MANUFACTURER (ROTOMED AG). FAILURE DESCRIPTION - THE PUSH BUTTON IS SEPARATED FROM THE AIR HOSE, SEE FIGURE 1. BESIDES THAT, THE DEVICE IS IN A GOOD CONDITION. INVESTIGATION - THE INVESTIGATION HAS BEEN CARRIED-OUT BY THE AESCULAP TECHNICAL SERVICE (ATS). THE DEVICE HAS BEEN DELIVERED IN JUNE 2019. ON THE HANDPIECE / MOTOR SIDE THE PUSH BUTTON GA405295 AND SPRINGS GA705294 BECAME LOOSE AND ARE ENCLOSED. AN IMPACT POINT CAN BE FOUND AT THE CASE WHICH COULD BE TRACED BACK TO A FALL. THEREFORE, IT IS POSSIBLE THAT THE ABOVE-MENTIONED PUSH BUTTON AND SPRING HAVE BECOME LOOSE. A FURTHER ANALYSIS IS NOT POSSIBLE. THE PRODUCT HAS BEEN FORWARDED TO THE MANUFACTURER. BATCH HISTORY REVIEW - THE DEVICE HISTORY RECORDS HAVE BEEN CHECKED FOR THE PROVIDED LOT NUMBER AND FOUND TO BE ACCORDING TO THE SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO FURTHER SIMILAR COMPLAINTS REGISTERED AGAINST THE SAME LOT NUMBER. CONCLUSION AND ROOT CAUSE - ON THE BASIS OF THE CURRENT INFORMATION, THE FAILURE IS MOST PROBABLY USAGE RELATED. RATIONALE - REFER TO INVESTIGATION. A FURTHER INVESTIGATION IS ONGOING. THIS REPORT WILL BE UPDATED IF NEW INSIGHTS ARISE. UPDATE 10.12.2019: AFTER THE INVESTIGATION BY THE MANUFACTURER (ROTOMED AG), THE ABOVE MENTIONED COULD BE CONFIRMED. IT IS MOST LIKELY THAT AN IMPACT (E.G. AFTER A FALL) LED TO THE REPORTED FAILURE PATTERN. THIS IS THE FIRST PRESENT CASE WITH THIS FAILURE PATTERN, THEREFORE WE SUSPECT AN INDIVIDUAL CASE. THERE IS NO INDICATION FOR A SYSTEMATIC FAILURE. CORRECTIVE ACTION - ACCORDING TO SOP SA-DE13-M-4-2-04-000-0 (PREVENTIVE ACTION AND CORRECTIVE ACTION) A CAPA IS NOT NECESSARY.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH ELAN 4 AIR MOTOR HOSE 3M. "AFTER SURGERY WHEN THE CUSTOMER TRY TO TAKE OFF THE HANDPIECE AND HOSE, AND THE CUSTOMER PUSHED THE BUTTON OF HOSE, TWO SPRINGS WAS POPPED OUT AND BROKEN. AT THIS TIME, THE HANDPIECE DID NOT COME OFF COMPLETELY AND THE SALES ASSEMBLE THE BUTTON AND TOOK OFF THE HANDPIECE. AND ALSO THERE WAS LOOSED OF PARTS AT THE HANDPIECE SIDE. IT HAS BEEN LESS THAN ONE MONTH SINCE THE CUSTOMER STARTED TO USE IT. WASHING PROCESS AND HANDLING HAS BEEN DONE ACCORDING TO OUR INSTRUCTIONS." THERE WAS NO PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE. THE ADVERSE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975267 ELAN 4 AIR MOTOR HOSE 3M W/HAND CONTROL HIGHSPEED POWER SYSTEMS HBB AESCULAP AG GA706R 52517443

    Patients

    Seq Age Sex Outcome Treatment
    1