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	03/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, the jaw symmetry was unbalanced and the jaws were misshaped.The distal end of the handpiece was examined under a microscope and heavy dried foreign residue located on the jaws was identified which is consistent with use.The device was received with the jaws opened, lock on.The jaw tips are the first point of contact as the jaws close, consistent with standard.The jaw mesh was not good.The insulation of the jaw legs was inspected and a scrape/tear exposing metal was found.The flare was intact and had no cracks.A functional test could not be performed with this device as the cord was cut and damaged.When the lock switch was on and the forceps grip on the handle was grasped, the jaws of the device did not close all the way and there was a gap between the jaws.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, as there was heavy dried amounts of tissue on the device, 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.
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.

• 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: 15090293
• Report Number: 3005975494-2022-00016
• Device Sequence Number: 14714718
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2022

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: 06/14/2022
• 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: 03/21/2022
• Initial Report FDA Received Date: 07/23/2022
• 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