MAUDE Adverse Event Report: GYRUS ACMI, INC DIEGO TRIGGER ENABLED HANDPIECE

Model Number	70339001
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned device was evaluated.Inspection found the reported issue was confirmed.The device was observed to be no output, the motor does not spin.The root cause of handpiece not working as intended was determined to be as a result of no motor function, there was no output.Per the handpiece manufacturing functional checklist, the handpiece was confirmed to run with both the trigger and foot switch.The handpiece was likely to have left the manufacturing facility free from motor failure damages.This suggests that the damages incurred, which resulted in motor failure, may have been as a result of transportation or customer use.Review of device history records for this product was performed.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.Olympus will continue to monitor complaints for this device.
Event or Problem Description
A report of handpiece not functioning as intended, will not rotate during an unknown event was reported.There was no patient involvement, no user injury reported due to the event.

• Brand Name: DIEGO TRIGGER ENABLED HANDPIECE
• Common Device Name: DIEGO TRIGGER ENABLED HANDPIECE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11738057
• Report Number: 1037007-2021-00032
• Device Sequence Number: 4168291
• Product Code: ERL
• UDI-Device Identifier: 00821925011410
• UDI-Public: 00821925011410
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K020594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 70339001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1