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

Model Number	920005PK
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the jaws of the forceps were bent and not aligned properly due to excessive force and/or user mishandling.Additionally, the jaw aperture measurement was taken inside the first teeth of the jaw, measured at about approximately.316", (standard is.300¿ +/-.100¿).The jaw mesh was not good.The insulation of the jaw legs was inspected and there was a cut and metal exposed.The flare had a crack.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been less than 1 year since the subject device was manufactured.Based on the investigation, the reported complaint could be attributed to the misshaped/misaligned jaws.The damage to the jaws was probably caused by user mishandling.However, the exact cause of the damage could not be conclusively specified.The device instructions for use (ifu_910111-001_ee) addresses this " if using the tip and shaft of the instrument to leverage tissue, ensure the jaws are closed to prevent deformation of the jaws." (page 2).Olympus will continue to monitor the field performance of this device.
Event or Problem Description
Olympus received a regulatory complaint report via email that a pks cut/fcp, 5mm/33cm 9-pin (5/pk) device had malfunctioned.The jaws were not closing properly during a therapeutic laparoscopically assisted vaginal hysterectomy (lavh) procedure.The procedure was complete with a second similar device.Inspection and testing of the returned device found the jaws of the forceps were bent and not aligned properly.There were no reports of patient harm.This medical device report (mdr) is being submitted to capture the reportable malfunction found during evaluation.

• 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, 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: 16872824
• Report Number: 3011050570-2023-00032
• Device Sequence Number: 14904431
• 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): 05/04/2023

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: FR251651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• 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: 02/01/2023
• Initial Report FDA Received Date: 05/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2022
• 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