MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS

Model Number	FD-410LR
Medical Device Problem Code	Failure to Seal (4070)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to the following linked patient identifiers: (b)(6).
Event or Problem Description
It was reported that during a endoscopic submucosal dissection (esd) procedure, the electrosurgical generator was used in combination with electrosurgical hemostatic forceps and the electrical output was weak and so hemostasis could not be achieved.The forceps was replaced by another one but no improvement in the ability to achieve hemostasis.The procedure was completed with another device with a delay of 10-15 minutes.Follow-up identified that saline was sprayed to clear bleeding site and drain the blood as the patient was bleeding a lot.The setting value of the device was normal (¿same as usual¿) but the bleeding could not be stopped.After replacing with another forceps, a cable cord from another manufacturer (a troubleshooting measure) and other similar device, the procedure was able to be completed.The device was inspected, and no abnormalities were found.Also, it was reported that there was no issue with the forceps used.
Event or Problem Description
Additional information received: it was reported that when using the subject device, after checking that it is powered on (after it is not burned), the output is increased.Since no change was observed after increasing the output, the connection of the device, a cord, and the return electrode was checked.No change was observed, and the device was replaced with the same model.Original setting: soft core aggregate effect 2 80w increase output for no-burn results = soft core aggregate effect 2 85w.Chronological details were provided and are as follows: 1.Esg-300 (electrosurgical generator) and fd-410lr (single use electrosurgical hemostatic forceps) combination hemostasis was performed, but no electricity was applied (no burning).Esg-300 settings at this time: original setting = softcore ag effect 2 80w 2.Reconnect the same cable (a cord and return electrode) in the situation of "1".No change (no burning) 3.In the "1" and "2" states, only the output value of the esg-300 is increased.Soft core 80w 85w no change (no burning) 4.Change the electric scalpel to an icc200.At this time, the fd-410lr was also replaced with a new one.The a cord was also replaced with an icc200 cord (it is unknown whether the return electrode was the same or replaced).Mode: soft core 80w the user was able to stop the bleeding (the burn) 5.After the treatment, the combination of fd-410lr and esg-300 used in "4" was used.Output checked on wet gauze (it is unknown whether the a cord at this time is the one from when it was "1" or a new a cord.).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additionally, to provide an update to fields (b5, h3, and h4).The device was evaluated by olympus.The reported phenomenon could not be replicated, and no abnormalities that could lead to the reported phenomenon were confirmed.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 that the reported event occurred due to the following: the connection between the plug and a cord, or a cord and the electrosurgical unit was insufficient.The condition of the bleeding area indicates that the area possibly contains high moisture content.Therefore, the high frequency current density has decreased.However, the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use which state: "before use, prepare and inspect the instrument and a cord as instructed below.Should the slightest irregularity be suspected, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforation, bleeding, mucous membrane damage or thermal injury and may result in more severe equipment damage." "aspirate fluids such as mucus that adhere to the tube and body cavity tissue.Patient injury such as perforation, bleeding, mucous membrane damage and thermal injury of tissue could result if output is activated with these fluids adhering." olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Common Device Name: SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20280934
• Report Number: 9614641-2024-01877
• Device Sequence Number: 7545993
• Product Code: KNS
• UDI-Device Identifier: 04953170208430
• UDI-Public: 04953170208430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FD-410LR
• Device Lot Number: 45K13
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 09/23/2024
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESG-300 ELECTROSURGICAL GENERATOR SN (B)(6).; FD-410LR (LOT NO. 45K).
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown