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

Model Number	HX-400U-30
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported, the single use litigator exhibited difficult to detach loop from polyp-loop.There were no reports of patient harm.
Event or Problem Description
It was also reported that during the endoscopic resection of the huge intestinal polyp, while attempting to release the nylon rope (loop), the wire broke and could not be released.The resection was interrupted.The loop had to be cut with the loop cutter and repeatedly pulled until it finally released.The polyp was finally removed as well.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation as well as corrected data in b1, b2, b5, h1, h6 (component code, impact code, problem code) and additional information in d8, h6.The device history record was unable to be reviewed for this device since the lot was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The device was not returned to olympus for inspection, and the reportable malfunction was not confirmed.Based on the investigation results in the past, there are two likely probable causes: probable cause 1: 1) the loop was placed around the body tissue.2) the tube sheath was pushed forward, and the tissue was temporarily ligated with the distal end of the tube sheath.3) the slider was pulled to tighten the loop.4) because the distal end of the coil was not extended from the tube sheath when the slider was pushed, the loop disengaged from the hook inside the tube sheath.5) the hook protruded from the distal end of the coil sheath, causing the loop to move toward the handle side and enter the coil sheath.6) pulling the hook caused both the hook and the loop to be drawn into the coil sheath together.As a result, the loop became trapped between the hook and the inner surface of the coil, preventing it from moving.7) because the loop is trapped between the hook and the inner surface of the coil, pushing the slider does not release the loop.8) the slider was forcefully operated in state of ¿7¿ description causing the operation pipe of the slider to deform and break.Probable cause 2: 1) the sheath was bent near the handle.2) the operating wire could not move because sliding resistance between the sheath and the operating wire increased.3) the operating pipe deformed and broke because the slider was forcefully operated.4) due to above, the loop could not detach from the hook.The instruction manual contains the following warnings: do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.Do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.Do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.Never use excessive force to operate the instrument.This could damage the instrument.Straighten out the portion of the instrument that extends from the biopsy valve.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20057563
• Report Number: 9614641-2024-01707
• Device Sequence Number: 8496115
• Product Code: MND
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 11/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown