MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER FOOTSWITCH

Model Number	MDFS100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was received and evaluated at olympus service business center (sbc) germany.Device evaluation and inspection, service repair noted during the physical investigation, the following errors were detected: cut on the cable.The surface of cable unit is cut at several times.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported that in the middle of a functional endoscopic sinus surgery (fess) procedure in nose, customer tried to stop the rotation of diego's terminal by releasing the footswitch.However; the blade kept on rotating at lower revolutions even though the footswitch was not pressed down.It did not cause any damage to patient as it was removed in time.The device was replaced.The intended procedure was completed with a backup footswitch.There was no patient harm, no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.Section d4 was corrected with information that was inadvertently left out of the initial report.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, and since no device malfunction was confirmed during evaluation, the definitive root cause of the footswitch issue could not be determined.It is possible that the footswitch issue was caused by mishandling from the user.Olympus will continue to monitor field performance for this device.

• Brand Name: MULTIDEBRIDER FOOTSWITCH
• Common Device Name: MULTIDEBRIDER FOOTSWITCH
• Manufacturer (Section D): GYRUS ACMI, INC; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15143724
• Report Number: 3003790304-2022-00133
• Device Sequence Number: 5530139
• Product Code: GEI
• UDI-Device Identifier: 00821925027787
• UDI-Public: 00821925027787
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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: MDFS100
• Device Lot Number: 354187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 10/11/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown