MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LOOP CUTTER FS-410

Model Number	FS-410U
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during a therapeutic colonoscopy and polyp removal, the endoloop placement was not what the physician quite wanted so the decision was made to use the loop cutter to cut and try again.During the attempt to cut the endoloop with a loop cutter, the cutter internally (inside sheath) must have pulled and snapped as the loop cutter would not open or close, was stuck on tissue, and the handle was not opening or closing the cutter.A wire cutter was used to cut the sheath from outside the handle and pull off the scope (do exchange and leave the sheath hanging outside the patient, go back in, and introduce surgical scissors to put the tissue to release the stuck loop cutter off of the patient).The procedure was completed without any reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the final investigation.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, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.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
No additional information received from the customer.

• Brand Name: SINGLE USE LOOP CUTTER FS-410
• Common Device Name: LOOP CUTTER
• 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: 22064352
• Report Number: 9614641-2025-00786
• Device Sequence Number: 12670961
• Product Code: PTS
• UDI-Device Identifier: 04953170401053
• UDI-Public: 04953170401053
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2025

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: FS-410U
• Device Lot Number: 44K
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ENDOLOOP.; ENDOSCOPE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown