MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

Model Number	HX-400U-30
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a single use ligating device malfunctioned during a therapeutic polypectomy performed during a colonoscopy.The patient was sedated, and the device was in use when the event occurred.A regular colonoscope was advanced to the cecum, where a large polypoid lesion/lipoma was noted in the ascending colon.The physician requested a ligating device to ligate the base.The ligating loop was deployed at the base of the polyp / lipoma and tightened appropriately; however, the loop failed to deploy from the sheath of device.Multiple attempts by the physician and nursing staff to deploy the loop were unsuccessful.The physician attempted to insert a pediatric colonoscope with the regular colonoscope to advance a loop cutter and free the stuck ligating device sheath from the regular scope; however, this attempt was unsuccessful and was abandoned.Wire cutters were then used to cut the portion of the ligating loop hanging out of the biopsy channel in an effort to detach the endoscope from the stuck ligating device.The colonoscope was withdrawn while biopsy forceps were advanced through the biopsy channel forcing the poly loop sheath to remain in patient while scope could be removed.The colonoscope was then reintroduced to the site of the lesion.A single use loop cutter was used to cut the loop strings past base, so the ligating device sheath could be removed from the patient leaving ligating device intact on polyp / lipoma base.During the loop-cutting procedure, visualization of the cutter jaws was limited because the cutting mechanism opened on only one side and the open side was not visible endoscopically.The physician removed and reinserted the cutter in an attempt to improve visualization; however, visualization remained limited.During cutting of the loop string, adjacent mucosal tissue was nicked.It was reported that no active bleeding was noted at base of the ligator or at the area nicked with loop cutter.No additional patient complications or requirement for additional intervention were reported.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.

• Brand Name: SINGLE USE LIGATING DEVICE
• Common Device Name: SINGLE USE LIGATING DEVICE
• 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 ; +1(508)207-7661
• MDR Report Key: 50828470
• Report Number: 9614641-2026-00938
• Device Sequence Number: 13407012
• Product Code: MND
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 61V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2026
• 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: Single Use Loop Cutter, FS-410, 66K.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown