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 Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The olympus service team received a 70339001 for the reported issue of malfunctioning, the unit did not operate when powered on.The handpiece was visually inspected for abnormalities.There were no discernible damages found.Furthermore, the handpiece underwent functional tests to assess the device status.The user report was confirmed, when the handpiece was plugged in, it did not move.There was confirmed to be no output.The definitive root cause could not be determined.However, during handpiece inspection and assembly, the handpiece is evaluated for proper motor activation.This suggests that the handpiece was shipped out free from damages, which may cause no motor activation.This implies that the damages incurred were as a result of transportation, or use.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that during an unspecified procedure the device was found not functioning as intended.The device when plugged in to power on, it did not function at all.There were no further details provided regarding the reported event.No known patient harm reported.No user injury reported.

• 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: 11010693
• Report Number: 1037007-2020-00100
• Device Sequence Number: 11822697
• Product Code: ERL
• UDI-Device Identifier: 00821925011410
• UDI-Public: 00821925011410
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K020594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/15/2020

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: 11/18/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 12/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1