MAUDE Adverse Event Report: GYRUS ACMI, INC. HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY

Model Number	MDHP200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
During therapeutic mastoidectomy (mastoid exploration) the surgeon was initially using the 5mm round cutting burr (high speed multi drill hand piece / otology), it made noise from friction with black oily fluid coming out of the device and the irrigating fluid turned black containing the field that required the surgeon to exchange the device to a 4mm course burr.It was reported the 4mm burr was difficult to insert and friction occurred again, and the device jammed when the surgeon attempted to exchange it out (with a 2mmb burr); however, the device remained operable, and the surgeon completed the procedure with this device but omitting some steps in the procedure.The device issues resulted in the procedure being lengthened by at least 40 minutes.Reportedly, an antifog solution was used at the end of the procedure and the burr was able to be removed.The is patient reported to be doing fine and no health hazards.
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 customer's complaint/reportable malfunction was not confirmed.The evaluation confirmed the following: the device performed as expected with a 4 mm burr and a short attachment.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the reported event occurred due to the attachment/burr usage and placement with the mdhp200.Attachments have been noted for misaligned bearings issues that can cause noise, friction, heat and smoke.As the incorrect attachment was sent back on the concomitant device complaint, a definite root cause cannot be determined as to why the irrigation fluid turned black and obscured the viewing field.Therefore, a specific root cause of the reported event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY
• Common Device Name: DRILL
• 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: 17627315
• Report Number: 1037007-2023-00020
• Device Sequence Number: 7386099
• Product Code: ERL
• UDI-Device Identifier: 00821925035607
• UDI-Public: 00821925035607
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K152744
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2024

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: MDHP200
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2015
• 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: MULTI DRILL ANGLED SHORT ATTACHMENT: MDASA
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown