MAUDE Adverse Event Report: GYRUS ACMI, INC DIEGO #2 ANG. VIPER H/PIECE

Model Number	70338031
Medical Device Problem Codes	Defective Device (2588); 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 device motor does not spin and no output.The reported customer issue of device not working was confirmed.Unrelated to the reported issue, minor scratches were observed on the housing.Investigation is ongoing.This report will be supplemented accordingly.
Event or Problem Description
It was reported that during preparation for use the device was reported seems not holding the burr attachment and not working.There was no patient involvement reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: g3, g6, h2, h6 and h10.The device was returned for physical inspection.Upon evaluation, user report of "not working" was confirmed.It was also noted that the motor does not spin, no output present, and locking mechanism failure for burr attachment.Minor scratches on the housing.An investigation was completed by the oem (original equipment manufacturer) and determined that the root cause of the locking mechanism failure is due to normal wear and tear.Olympus will continue to monitor the field performance of this device.

• Brand Name: DIEGO #2 ANG. VIPER H/PIECE
• Common Device Name: DIEGO #2 ANG. VIPER H/PIECE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12063836
• Report Number: 1037007-2021-00046
• Device Sequence Number: 3870534
• Product Code: ERL
• UDI-Device Identifier: 00821925011397
• UDI-Public: 00821925011397
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K992994
• 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): 07/13/2021

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: 70338031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 06/24/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1