MAUDE Adverse Event Report: GYRUS ACMI, INC. HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY; ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, PNEUMATIC

Model Number	MDHP200
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
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
The serial number of the device referenced in this report is unknown.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.The device referenced in this report was not returned to olympus and therefore, an evaluation could not be completed to confirm or not confirm the allegation.The device history record was unable to be reviewed, as the lot number was not provided.The investigation determined that there is no manufacturing, material, or processing related cause for this failure mode.The root cause has been determined to be use error as the customer stated that the hand piece did not work because it was not properly connected to the console.The customer has decided not to return the hand piece, thus the reported failure is not confirmed.Olympus will continue to monitor the field performance of this device.

• Brand Name: HIGH SPEED MULTI DRILL HAND PIECE / OTOLOGY
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, PNEUMATIC
• 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: 16186210
• Report Number: 1037007-2023-00006
• Device Sequence Number: 2661539
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: MDHP200
• Was Device Available for Evaluation?: No
• 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: 02/07/2023
• Initial Report FDA Received Date: 01/17/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: MDCONS100 WITH SERIAL NUMBER: (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown