MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER HANDPIECE, STRAIGHT

Model Number	MDHP100S
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated.The handpiece is visually inspected for abnormalities.There were no discernible damages found on the handpiece.Moreover, the handpiece also underwent functional tests to assess the device status.The reported issue was confirmed.The handpiece was found to fail the gnd to hall b test, there was no output.The dhrs for this product have been reviewed.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.No issues found or deviations relating to the reported failure.The definitive root cause of the handpiece not activating could be attributed to the handpiece failing the gnd to hall b test, resulting in the handpiece getting an error.However, the diego elite functional checklist showed that the handpiece undergoes a set of tests with a test console prior to being shipped out.It is necessary for the handpiece to be recognized by the console in order to move forward with the functional tests, which include basic motor activation at a specific setting.This suggests that the handpiece was shipped free from damages resulting in the inability to be operated.This may mean the damages incurred may be a result of transportation or user handling.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that during an unknown procedure the device was found not functioning as intended.The device was plugged in and did not work.There was no patient harm or injury reported due to the event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the customer on (b)(6) 2021.The customer stated that the event occurred during a endoscopic sinus surgery.There was no delay in the procedure.The procedure was completed using a different device (model and serial number of replacement device not provided).No other devices were involved or replaced in this event.There was no patient injury as a result of this event.The device did turn on, it just did not recognize the handpiece.The facility did not provide any patient demographics.

• Brand Name: MULTIDEBRIDER HANDPIECE, STRAIGHT
• Common Device Name: MULTIDEBRIDER HANDPIECE, STRAIGHT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11225138
• Report Number: 1037007-2021-00012
• Device Sequence Number: 17159157
• Product Code: GEI
• UDI-Device Identifier: 00821925027756
• UDI-Public: 00821925027756
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2021

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: MDHP100S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1