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	07/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was reported that during an unknown procedure, the single use electrosurgical hemostatic forceps did not provide hemostasis and the bleeding did not stop.Additional information was requested but not available at this time.There were no further reports of patient harm.
Event or Problem Description
Additional.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer.Updated fields: b5 and h6.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction.Corrected fields: b5, d4 - expiration date and h4.
Event or Problem Description
Additional information was received from the customer that the bleeding was categorized as mild bleeding with small amount of blood.The patient was stable all throughout the procedure.The procedure was completed with a similar device.There were no further reports of patient harm.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 22794016
• Report Number: 9614641-2025-01369
• Device Sequence Number: 15581363
• Product Code: KNS
• UDI-Device Identifier: 04953170208430
• UDI-Public: 04953170208430
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: FD-410LR
• Device Lot Number: 4ZK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 01/26/2026
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/08/2025; 01/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2024
• 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
• Patient Sex: Unknown