MAUDE Adverse Event Report: GYRUS ACMI L.P. BURR, 6MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA; BUR, EAR, NOSE AND THROAT

Model Number	MBUR6060FRCV
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
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
Additional concomitant devices include mdhp200 with serial number (b)(4) 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
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: per the evaluation of the picture of the device provided, the customer complaint was 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 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that when the customer dropped the device, the impact caused the burr to break.Therefore, the reported event is due to mishandling of the device.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide an update to the legal manufacturer's final investigation.The root cause of (b)(6).Breaking in the (b)(4)was because of the substantial heat and stress caused by the attachment, mdasa, that was used in conjunction with the (b)(4).The pictures provided show signs of a char along the breakage of the burr that corroborates with the heat and stress caused by the attachment.As evaluation of the device passed all inspections, it is unlikely the device left the facility damaged and/or not within specification.Therefore, the damaged reported is a result of the attachment, mdasa, that was used in conjunction to the burr and hp in the procedure.The bearings in the attachment were misaligned and caused the reported failure.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is (b)(4).

• Brand Name: BURR, 6MM ROUND CUTTING 10-25 MM VAR EXPOSURE, USE WITH MDSSA AND MDASA
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16186237
• Report Number: 1037007-2023-00008
• Device Sequence Number: 14095990
• Product Code: EQJ
• UDI-Device Identifier: 00821925036536
• UDI-Public: 00821925036536
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT-EQJ
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/19/2024

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: MBUR6060FRCV
• Device Lot Number: AV114727
• 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: 02/08/2023; 09/20/2023; 06/19/2024
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/16/2023; 09/21/2023; 06/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MDSSA WITH SERIAL NUMBER (B)(4)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown