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	Energy Output Problem (1431)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation and the investigation is underway.The root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
Olympus was informed of a report that the instrument continued to seal even when the foot pedal was released (deactivated).The problem occurred during a laparoscopic eug procedure.The intended procedure was successfully completed, after a short delay of unspecified time, using bipolar forceps from a gynecological laparoscopy set and scissors.There was no patient injury, associated with the problem, reported to olympus.
Additional Manufacturer Narrative
Upon further review, this is not a reportable malfunction.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: CUT/FCP,5MM/33CM DESIGN III (5/PK)
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11803250
• Report Number: 3003790304-2021-00084
• Device Sequence Number: 11674133
• Product Code: GEI
• UDI-Device Identifier: 00821925035881
• UDI-Public: 00821925035881
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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 Expiration Date: 03/03/2023
• Device Model Number: 3005
• Device Lot Number: FR916733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/18/2021
• Supplement Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 05/10/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1