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

Model Number	70339001
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that the handpiece device is not functioning as intended, not responding and not working.The motor was defective.The issue occurred during preparation for use.The intended procedure was completed using another handpiece.Serial number used was not provided.There was no patient involvement, no user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The subject device has not been returned for evaluation.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.An investigation was completed by the oem and determined that the definitive root cause could not be determined to identify the failure mode.The probable root cause has been determined to be attributed to the mating mechanism within the handpiece in which gears within the handpiece have became misaligned or worn.Olympus will continue to monitor the field performance of this device.

• Brand Name: DIEGO TRIGGER ENABLED HANDPIECE
• Common Device Name: ENABLED HANDPIECE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11486199
• Report Number: 1037007-2021-00025
• Device Sequence Number: 11530999
• Product Code: ERL
• UDI-Device Identifier: 00821925011410
• UDI-Public: 00821925011410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2021

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
• Device Catalogue Number: 70339001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 03/15/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1