MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER POWER CONSOLE

Model Number	MDCONS100
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer have not returned the subject device.The definitive root cause could not be confirmed as it was later reported that the device was found to be functional.Olympus will continue to monitor complaints for this device.
Event or Problem Description
It was reported that the device console not functioning as intended, foot pedal connection issue.The console would not read the foot pedal.There was no patient involvement on this event.No user injury reported.

• Brand Name: MULTIDEBRIDER POWER CONSOLE
• Common Device Name: MULTIDEBRIDER POWER CONSOLE
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11345198
• Report Number: 1037007-2021-00021
• Device Sequence Number: 17402247
• Product Code: GEI
• UDI-Device Identifier: 00821925027770
• UDI-Public: 00821925027770
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 02/18/2021

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: MDCONS100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1