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

Model Number	920005PK
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the reported issue is unknown at this time.Supplemental report(s) will be submitted should any relevant new information is available and or received.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
It was reported the device model 920005pk with lot fr207931 malfunctioned.The " jaw not opening and closing properly".The issue found during a therapeutic laparoscopically assisted vaginal hysterectomy (lavh) procedure.The device was replaced with the same model (920005pk) with lot number not provided and the intended procedure was completed with no patient harm or adverse event reported.There was no user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's final investigation.The subject device was received and evaluated.The device was returned in the original packaging however opened and used and the returned lot number was verified.The device was received with the jaws opened, lock on.A visual inspection indicates that there is heavy amounts of dried tissue on the jaws consistent with use.The jaw symmetry is not balanced as the jaws appear to be misaligned.The first point of contact for the jaws is at the distal end; this is consistent with standard.The jaw aperture measurement was taken inside the first teeth of the jaw, measured at about.213" which is within standards, (standard is.300¿ +/-.100¿).The jaw mesh is no good as the jaws appear misaligned.The insulation of the jaw legs were inspected and no cuts or tears were identified on the insulation.The flare is intact and has no cracks.The blade extends/retracts and cuts dental dam as designed, however there is restriction as there is heavy amounts of dried tissue on the blade.The lock function engages/releases as designed however there is heavy restriction when releasing the lock function.Testing performed, observed that the "ratchet" lock button on the top of the handle was stuck on the "on" position and was unable to set it to the "off" position.The shaft appears normal as there are no dents or deformities found.The device was plugged into the test generator; the generator displayed vp3/35; this is the correct default setting.Additionally a test gyrus g400 generator was used in conjunction with the 920005pk hand piece and verified that energy was being transferred to the distal end of the forceps during activation, which was visually represented by vapors of moisture during contact with the wet cotton pad soaked in saline when coag pedal (blue foot pedal) was activated.Based on the device evaluation, it was confirmed that the jaws were not opening and closing properly and it could likely be attributed to mishandling as there were heavy amounts of dried tissue identified on the distal end of the device which is consistent with use as well as the jaws appearing to be misaligned.The observed failure is a known phenomenon likely resulting from having excess bodily material buildup on the distal jaw end, introducing heavy resistance opening and closing the jaws.Instruction for use (ifu): on page 3 of the device ifu (910111-001_ee), it states: "regularly check the device and cord/cable for damage during the procedure." the device history records (dhr¿s) for this product have been reviewed.All records indicate that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Dhr review for this lot found no associated ncrs (nonconformance's), reported scrap or recorded process deviations relating to the reported failure.Olympus will continue to monitor complaints for this device.

• Brand Name: PKS CUT/FCP, 5MM/33CM 9-PIN (5/PK)
• Common Device Name: ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• Manufacturer (Section D): GYRUS ACMI, INC; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 5082077661
• MDR Report Key: 15636234
• Report Number: 3005975494-2022-00053
• Device Sequence Number: 7169223
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2023

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: 920005PK
• Device Lot Number: FR207931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 12/12/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 01/09/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown