MAUDE Adverse Event Report: GYRUS ACMI, INC. CUT/FCP,5MM/33CM DESIGN III (5/PK); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	3005
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the energy device was operating poorly during a therapeutic myomectomy procedure.The procedure was completed using a similar device and there were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
B5: no additional information received from customer.D8: additional information.D9: additional information.H2: additional information, device evaluation.H3: additional information.H4: additional information.H6: additional information.The device was returned to olympus for inspection and the reported failure was confirmed.A root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: this event was caused by an open circuit resulting from a component failure in the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from the customer.
Additional Manufacturer Narrative
B5: no additional information received from customer.H2: correction.H4: correction.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
No additional information received from customer.

• Brand Name: CUT/FCP,5MM/33CM DESIGN III (5/PK)
• 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: 23000347
• Report Number: 3011050570-2025-01024
• Device Sequence Number: 15655082
• Product Code: GEI
• UDI-Device Identifier: 00821925035881
• UDI-Public: 00821925035881
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K023492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2026

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: 3005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/26/2025; 04/07/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/15/2025; 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/16/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown