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

Model Number	3005PK
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported to olympus that the pks cutting forceps has no energy when activated at full range.The issue was found during the therapeutic total laparoscopic hysterectomy procedure which was completed with no delay and with a similar device.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
The device was not returned to olympus for inspection, and the customer's complaint was not confirmed.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, the root cause was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: CUT/FCP,5MM/33C 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: 18051832
• Report Number: 3011050570-2023-00168
• Device Sequence Number: 8077862
• Product Code: GEI
• UDI-Device Identifier: 00821925036000
• UDI-Public: 00821925036000
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K023492
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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 Expiration Date: 12/27/2025
• Device Model Number: 3005PK
• Device Lot Number: FR272681
• 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: 10/10/2023
• Supplement Date Received by Manufacturer: 01/05/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3005PK.
• Patient Sex: Unknown