MAUDE Adverse Event Report: GYRUS ACMI, INC. MULTIDEBRIDER POWER CONSOLE; ENT SHAVER SYSTEM

Model Number	MDCONS100
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: additional concomitant devices include mdssa with serial number: (b)(4), mbur6060frcv with lot number: av114727 and mdhp200 with an unknown serial number.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.
Event or Problem Description
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.
Additional Manufacturer Narrative
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: a cracked middle housing.Also, a 10% lower than expected bipolar power output, and the blade (bipolar ta) id test was found to be slightly out of calibration.This cracked middle housing could have been a result of transportation and or handling of the device per the customer.All other tests passed in accordance with the oem service manual.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 5 years since the subject device was manufactured.Based on the results of the investigation, it was determined that there was no manufacturing, material or processing related cause for this reported failure.The root cause is likely attributed to the attachment (mdssa) used in conjunction with the hp device (mdhp200) and console in the procedure.This attachment can cause excessive heat if the bearings are worn out or misaligned within the hp device (mdhp200).Olympus will continue to monitor field performance for this device.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: ENT SHAVER SYSTEM
• Manufacturer (Section D): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer (Section G): GYRUS ACMI, INC.; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16186216
• Report Number: 1037007-2023-00007
• Device Sequence Number: 19475556
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MDCONS100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2022
• Supplement Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MDHP200 WITH SERIAL NUMBER: (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown