MAUDE Adverse Event Report: GYRUS ACMI L.P. PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK); ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	920005PK
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the jaws of the subject device were not closing properly during a laparoscopically assisted vaginal hysterectomy.The procedure was completed with another similar device.The subject device was sent to olympus for evaluation.During inspection and testing, the jaw symmetry was unbalanced and the jaws were misshaped.This report is being submitted for the malfunction found during evaluation (jaws not aligned).There was no effect on the patient or user due to the event.
Additional Manufacturer Narrative
During inspection and testing, the jaw symmetry was unbalanced and the jaws were misshaped.The device was received with the jaws opened, lock on.A visual inspection indicated that there was minor dried tissue on the jaws consistent with use.Additionally, the jaws and jaw teeth had visible scuff marks, along with bent jaw teeth closer to the distal end.The first point of contact for the jaws was at the distal end; this is consistent with standard.The jaws would not completely close when using the lock function, after releasing the forceps grip.Additionally, a test gyrus g400 generator was used in conjunction with the 920005pk hand piece and it was confirmed that energy was transferred to the distal end during activation which was visually represented by vapors of moisture during contact with the wet cotton pad when the foot pedal was activated.This was performed multiple times while adjusting output indicating the device was working properly.A review of the device history record found no deviations that could have caused or contributed to the misaligned jaws.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, the device's coagulation features operated as intended.However, as there were signs of usage, the observed failure is a known phenomenon likely resulting from using the device through resistance and/or putting excess stress on the device's distal tip.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.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 15089160
• Report Number: 3005975494-2022-00014
• Device Sequence Number: 4119465
• Product Code: GEI
• UDI-Device Identifier: 00821925036178
• UDI-Public: 00821925036178
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/22/2022

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: FR172751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 07/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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
• Patient Sex: Unknown