MAUDE Adverse Event Report: GYRUS ACMI L.P. PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK); CUTTING FORCEPS

Model Number	920005PK
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that, during a myoma procedure, the subject device could not be recognized by the electrosurgical unit multiple times.The procedure was completed using a similar device.It was noted that the user has experience with the device.The subject device was sent to an olympus service center for evaluation.During inspection and testing, the insulation was found to be torn.This report is being submitted for the malfunction found during evaluation (torn insulation).There was no effect on the patient due to the event.
Additional Manufacturer Narrative
The subject device was sent to olympus for evaluation.When the device was received, the jaw mesh appeared to be misaligned and the insulation appeared to be torn.The handle, shaft, and distal jaws looked to be in good physical condition without physical damage.The handle was able to open and close the jaws as intended.The handle locking mechanism operated as intended.The cutting blade was sharp and in good condition without physical damage.Upon reviewing under a microscope, the distal teeth of each jaw did not align when open or closed.Further, the black jaw insulation was ripped in two locations, exposing the proximal jaw metal.When testing the device for functionality, the handle was able to smoothly open and close the jaws and grasp.When plugging the device into an esg400 generator, the generator immediately recognized the device.Further, the device was able to heat up and cut as intended, seen by steam when testing on a damp saline rag.Since the device was recognized by the generator right away, the initial complaint cannot be confirmed.A review of the device history record found no deviations that could have caused or contributed to the torn insulation.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely the torn insulation was due to wear on the distal end causing damage near the jaw and surrounding locations.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury." olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this issue and any required mdr reporting.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Common Device Name: CUTTING FORCEPS
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15396706
• Report Number: 3005975494-2022-00040
• Device Sequence Number: 17407565
• Product Code: GEI
• UDI-Device Identifier: 00821925036178
• UDI-Public: 00821925036178
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K023492
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2022

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: 920005PK
• Device Lot Number: FR166611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 09/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GYRUS ELECTROSURGICAL GENERATOR
• Patient Sex: Unknown