MAUDE Adverse Event Report: GYRUS ACMI L.P. PK CUTTING FORCEPS, 5MM, 33CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PK-CF0533
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not 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.
Event or Problem Description
The customer reported to olympus, the pk cutting forceps, clamp was not working.Since the clamp was not coagulating and no screen error was shown, the clamp was replaced with another clamp of the same model (pk-cf0533).The clamp was changed immediately so it was not necessary to extend the procedure and the patient´s condition was not affected by the reported failure.The issue was found during an unknown procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 event could not be determined.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 (b)(4).

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 18360841
• Report Number: 9610773-2023-03689
• Device Sequence Number: 7922199
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 06/20/2024

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: ACC-PW308563-SAM-01
• Was Device Available for Evaluation?: No
• 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: 12/01/2023
• Supplement Date Received by Manufacturer: 03/14/2024; 06/20/2024
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 03/18/2024; 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown