MAUDE Adverse Event Report: GYRUS ACMI L.P. DISSECTOR FCP,5MM/33CM (5/PK); ELECTROSURGICAL INSTRUMENTS

Model Number	3700
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for evaluation but the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
An olympus employee reported on behalf of a customer, the dissector was open and observed to have a deformation on the jaw tip under laparoscopic view.The event occurred at the beginning of a therapeutic laparotomy.The forceps were drawn out and replaced with another device.There was no report of medical intervention or patient harm associated with this event.
Additional Manufacturer Narrative
The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.Olympus inspected the device and found an extra small piece of metal attached to the jaws.The metal piece seemed to be made of the same material as the jaws themselves.Upon closer examination using a microscope, it was determined that the metal piece was simply stuck on.Attempts were made to remove it using pliers, but despite applying a high amount of force, the piece remained in place.No other damage was found on the device.The device was then plugged into a bipolar generator.The device was able to coagulate without any issues.The device functioned as intended.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the phenomenon occurred due to a manufacturing deviation at the original equipment manufacturer (oem) site.The oem was able to simulate the conditions and demonstrate how the contaminating material could become sintered to the jaw face.In response, the supplier will implement cleaning and inspecting procedures for the sintering setters as an additional measure to prevent similar incidents in the future.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This report is being supplemented to provide a correction to the initial report e1 (name) and e3.
Additional Manufacturer Narrative
Correction: d3, g1, h11.This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 3011050570.

• Brand Name: DISSECTOR FCP,5MM/33CM (5/PK)
• Common Device Name: ELECTROSURGICAL INSTRUMENTS
• Manufacturer (Section D): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI L.P.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16686536
• Report Number: 3005975494-2023-00056
• Device Sequence Number: 3585119
• Product Code: GEI
• UDI-Device Identifier: 00821925035928
• UDI-Public: 00821925035928
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K031080
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/17/2024

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: 3700
• Device Lot Number: FR259535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• 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: 03/08/2023
• Supplement Date Received by Manufacturer: 05/01/2023; 06/23/2023; 07/19/2023; 06/17/2024
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 05/22/2023; 07/18/2023; 08/04/2023; 06/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2022
• 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