BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY

    MDR report key: 16185934 · Received January 17, 2023

    Report

    Report Number
    1037007-2023-00005
    Event Type
    Injury
    Date Received
    January 17, 2023
    Date of Event
    December 21, 2022
    Report Date
    September 21, 2023
    Manufacturer
    GYRUS ACMI, INC.
    Product Code
    ERL
    UDI-DI
    00821925035607
    PMA / PMN Number
    K152744
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE AN UPDATE TO THE LEGAL MANUFACTURER'S FINAL INVESTIGATION. PER THE REPORTED FAILURE AND EVALUATION OF THE DEVICE(S) RETURNED, THIS REPORTED FAILURE IS A REPORT OF THE ATTACHMENT (MDSSA) HAVING BEARING ISSUES THAT COULD HAVE RESULTED IN THE OVERHEATING OF THE HP. BUT THE ACTUAL MDHP200-(040658) FUNCTIONED PROPERLY AND DID NOT OVER HEAT WHEN ANOTHER ATTACHMENT AND BURR WHERE CONNECTED FOR EVALUATION TESTING, THEREFORE THE CUSTOMER REPORTED IS NOT CONFIRMED FOR THE MDHP200. LOSS OF BEARING SUPPORT AROUND THE BURR IN THE ATTACHMENT MDSSA IS THE REASON FOR GENERATING HIGH HEAT AND THE HANDPIECE GETTING SUPER HOT DURING THE PROCEDURE. DAMAGE TO THE ATTACHMENT/BEARINGS COULD HAPPENED DURING TRANSPORT, MISALIGNING THE BEARINGS IN THE ATTACHMENT CAUSING FRICTION AND IN TURN CAUSING HEAT WITHIN THE HP. WHEN THE BEARINGS FAIL, THE ROTATING SHAFT LOSES SUPPORT, CAUSING IT TO WOBBLE AND VIBRATE, GENERATING HEAT AROUND THE HANDPIECE, FURTHER DAMAGING THE BURR DISPOSABLE, AND ULTIMATELY IN THIS CASE, THE DRILL BIT CAN BREAK IN HALF DUE TO HEAT AND FRICTION. AS THIS DEVICE WAS INSPECTED PER DHR REVIEW, EVALUATION OF THE DEVICE PASSED ALL INSPECTIONS, IT IS UNLIKELY THE DEVICE LEFT THE FACILITY DAMAGED. THEREFORE, THE DAMAGED REPORTED IS A RESULT OF BEARINGS ISSUES IN THE ATTACHMENT (MDSSA) DUE TO POSSIBLE TRANSPORTATION MEASURES OF THE ATTACHMENT USED IN COMBINATION WITH THE MDHP200. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL CONCOMITANT DEVICES INCLUDE MBUR6060FRCV WITH LOT NUMBER AV114727, AND MDCONS100 WITH SERIAL NUMBER (B)(4). THE DEVICE HAS NOT BEEN RETURNED TO OLYMPUS AT THIS TIME. THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION OR WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUPPLEMENTED TO PROVIDE ADDITIONAL INFORMATION BASED ON THE LEGAL MANUFACTURER'S FINAL INVESTIGATION AND DEVICE EVALUATION. THE DEVICE WAS RETURNED TO OLYMPUS FOR INSPECTION, AND THE FINDINGS ARE AS FOLLOWS: VISUAL AND FUNCTIONAL TESTING CONFIRMED THAT THE SUBJECT DEVICE (MDHP200) FUNCTIONED WITHIN SPECIFICATION WITH NO REPORTED FAILURES NOR ISSUES. THERE WERE NO OTHER ABNORMALITIES NOTED DURING THE INSPECTION. PER THE EVALUATION RESULTS, THE CUSTOMER¿S REPORTED COMPLAINT WAS NOT CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. IT HAS BEEN OVER 7 YEARS SINCE THE SUBJECT DEVICE WAS MANUFACTURED. BASED ON THE RESULTS OF THE INVESTIGATION, IT WAS CONFIRMED THAT THERE WERE NO MANUFACTURING, MATERIAL OR PROCESSING RELATED CAUSES FOR THE REPORTED FAILURE MODE. THE ROOT CAUSE OF THE REPORTED EVENT IS LIKELY RELATED TO THE DEVICE OVERHEATING DUE TO THE ATTACHMENT (MDSSA) USED IN CONJUNCTION WITH THE SUBJECT DEVICE (MDHP200). IN ADDITION, DAMAGE TO THE ATTACHMENT/BEARINGS WAS LIKELY DUE TO EXCESSIVE WEAR OF THE DEVICE. THIS SUPPLEMENTAL REPORT INCLUDES AN UPDATE TO D9 AND H3 FROM THE INITIAL MEDWATCH. ALSO, INFORMATION HAS BEEN ADDED TO D8 AND H4. OLYMPUS WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR THIS DEVICE.

    Description of Event or Problem · 0

    AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS, ON BEHALF OF THE CUSTOMER, THAT THE OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE WITH THE SHORT MASTOID ATTACHMENT, BECAME SUFFICIENTLY HOT TO BURN THROUGH METAL AND CAUSED SEVERE, FIRST-DEGREE BURNS WITH BLISTERING TO THE PHYSICIAN'S TWO FINGERS DURING A THERAPEUTIC MASTOID PROCEDURE FOR CHOLESTEATOMA. THE BURNS WERE TREATED WITH COLD APPLICATION. THE PHYSICIAN HAD ONLY BEEN USING IT FOR LESS THAN A MINUTE. THE HAND PIECE REPORTEDLY STARTED SMOKING AND SMELLED LIKE BURNING METAL SIMILAR TO A FIRED GUN. IN ADDITION, THE BURR PIECE BROKE INSIDE THE HANDPIECE. THE PHYSICIAN ATTEMPTED TO USE ANOTHER OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE BUT THERE WERE MORE "ISSUES" NOTED AND THE DIEGO ELITE SYSTEM CONSOLE REPORTEDLY "MALFUNCTIONED" AS WELL. THE CUSTOMER BELIEVED THAT THE SECOND HANDPIECE WAS INCORRECTLY ATTACHED TO THE CONSOLE AND ATTRIBUTED THE ISSUE TO EITHER THE CONSOLE OR USER ERROR. THE PROCEDURE WAS CANCELLED, AND THE PATIENT WAS DISCHARGED. THERE WAS NO FURTHER HARM OR USER INJURY REPORTED. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE FIRST OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SHORT MASTOID ATTACHMENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE BURR PIECE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DIEGO ELITE SYSTEM CONSOLE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE REPLACEMENT OTOLOGY HIGH SPEED MULTI DRILL HAND PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223732 HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, PNEUMATIC ERL GYRUS ACMI, INC. MDHP200 00821925035607

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other MDSSA WITH SERIAL NUMBER: (B)(6).