MAUDE Adverse Event Report: GYRUS ACMI L.P. PK CUTTING FORCEPS, 5MM, 33CM

Model Number	PK-CF0533
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon at the user facility reported that during a laparoscopic bilateral salpingectomy, the plasmakinetic cutting forceps were ¿not cutting properly, even with adequate amount of tissue in the forceps.¿ no error was displayed on the machine and the procedure was completed with a similar device.No delay and no harm or impact to the patient was reported.
Additional Manufacturer Narrative
The investigation is still in progress; however, if additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and to correct g2 and h4.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 of the suggested event could not be concluded.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
Correction: d3, g1, h11.This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3011050570.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Common Device Name: FORCEPS
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17206324
• Report Number: 9610773-2023-01737
• Device Sequence Number: 5440654
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2024

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: PK-CF0533
• Device Lot Number: FR240430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 06/18/2024
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 10/24/2023; 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2022
• 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
• Patient Sex: Unknown