MAUDE Adverse Event Report: GYRUS ACMI, INC. MULTIDEBRIDER FOOTSWITCH; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	MDFS100
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus, the diego elite multidebrider footswitch was not responding.The issue was found during preparation for use.The customer had experienced an issue a few days beforehand and was wiggling the wire but now there was no response at all.There were no reports of patient harm.
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This supplemental report is to provide a correction to the pervious initial report mdr as a non-reportable malfunction was reported.The initial medwatch reported that the diego elite multidebrider footswitch was not responding.The issue was found during preparation for use.The customer had experienced an issue a few days beforehand and was wiggling the wire but now there was no response at all.There were no reports of patient harm.The initial report was reported out of caution as there wasn't enough information.The iuc is non-pae and the final fuc codes are non-pae.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• Brand Name: MULTIDEBRIDER FOOTSWITCH
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18177601
• Report Number: 3011050570-2023-00193
• Device Sequence Number: 7890167
• Product Code: GEI
• UDI-Device Identifier: 00821925027787
• UDI-Public: 00821925027787
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2024

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: TBC
• Was Device Available for Evaluation?: Yes
• 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: 10/29/2023
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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