MAUDE Adverse Event Report: GYRUS ACMI, INC HIGH SPEED MULTI DRILL ANGLED SHORT ATTACHMENT; ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, PNEUMATIC

Model Number	MDASA
Medical Device Problem Codes	Overheating of Device (1437); Smoking (1585)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the drill in the handpiece is triggered.The handpiece became very hot during the procedure and smoke was produced.This prolonged the operating time.The customer was able to continue with his own system".There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
Communication with the customer , the following information conveyed: patient was under anesthesia at the time of the event.According to the customer, delay in the procedure due to the event caused no harm to patient (prolongation of the procedure not considered by the user as a serious deterioration of a person's health ("clinically relevant") to which this medical device may have contributed.Procedure involved was a mastoidectomy.According to the reporter, the heating of the handpiece did not cause any harm or injury to the patient or user.The drill device used with the handpiece noted to be model: egmbur6060frcv, lot: av121761.The subject device was returned to olympus service business center and is being shipped to the legal manufacturer for investigation.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This supplemental report is being submitted to correct the initial mdr.Corrected data: b1, h1: upon further investigation, the legal manufacturer determined the reported event does not meet the definition of a reportable malfunction since malfunction has not caused or contributed to a serious injury; no adverse events reported.No patient or user harm per customer.

• Brand Name: HIGH SPEED MULTI DRILL ANGLED SHORT ATTACHMENT
• Common Device Name: ARTHROSCOPIC SHAVER SYSTEM HANDPIECE, PNEUMATIC
• Manufacturer (Section D): GYRUS ACMI, INC; 2925 appling rd; bartlett TN 38133
• Manufacturer Contact: todd brill ; 2925 appling rd; bartlett, TN 38133 ; 5082077661
• MDR Report Key: 15408739
• Report Number: 1037007-2022-00016
• Device Sequence Number: 5640772
• Product Code: ERL
• UDI-Device Identifier: 00821925035621
• UDI-Public: 00821925035621
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MDASA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: (B)(4) LOT: AV121761
• Patient Sex: Unknown