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

Model Number	PK-CF0533
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that cutting forceps do not seal properly.The issue was found during an unspecified procedure.There were no reports of patient harm.
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported that cutting forceps do not seal properly, when grasping the fabric, the device did not work properly.The issue was found at the beginning of a therapeutic procedure.The intended procedure was completed using a new device.There were no reports of harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained from the customer and completion of investigation.Please see updates to b5, d8, h6 and h10.The subject device was returned to an olympus repair center for evaluation however the customer¿s reported issue was unable to be reproduced,.The device evaluation found dents/scratches on jaw insulation without any exposed metal.No other physical defects were found.Functional tests were conducted, and the device worked as intended.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 8 months since the subject device was manufactured.The root cause for the reported issue cannot be definitely determined.However, the observed failure is a known phenomenon likely resulting from having the distal jaw tips come in contact with each other when attempting to coagulate.On page 3 of the device ifu , it states: "if forceps jaws come in contact with each other when the power is activated, instrument will short out and the generator display will show ¿re-grasp¿.Release the forceps jaws so they are not in contact with each other and the device will become operational." also, on page 3 it states: "both forceps jaws should be in equal contact with tissue for optimum coagulation." if the device's coagulation feature is activated on a thin or uneven layer of tissue being grasped, the forceps may pierce the tissue and/or come in contact with each other.This would cause the re-grasp error to come up on the generator.This would then indicate that the distal jaws would need to be re-positioned to grasp the optimal section of tissue.Olympus will continue to monitor the field performance of this device.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Common Device Name: CUTTING FORCEPS
• 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: 17482419
• Report Number: 3011050570-2023-00112
• Device Sequence Number: 15697009
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

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: FR276278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 08/08/2023
• Supplement Report FDA Received Date: 09/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown