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

Model Number	HX-400U-30
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additionally, to provide correction to the initial with information inadvertently left out (g2) and to provide a correction to field (e3).The subject device was manufactured on september 2021 based on the provided 3 digit lot information "17v".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 past investigation results, a likely mechanism causing the reported events could be one of the following: mechanism 1 : 1) the loop was surrounding the body tissue.2) the tube sheath was pushed out, and the body tissue was temporarily ligated by using the distal end of the tube sheath.3) the loop was tightened by pulling the slider.4) the slider was pushed while the distal end of coil sheath did not extend from the tube sheath.Therefore, the loop detached from the hook in the tube sheath.5) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.6) the hook was pulled.This caused the hook and the loop to retract into the coil sheath together.As a result, the loop and the hook got stuck inside the coil and could not move.7) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.Mechanism 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 because the slider was forcefully operated.4) due to above, the loop could not detach from the hook.However, the subject device was not returned, and the root cause of the suggested event could not be determined.The event can be prevented by following the instructions for use which state: "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.In this case, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "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.In this case, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "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.In this case, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency." "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.
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 that during an unspecified procedure, the single use ligating device could not be released (presumed from a polyp).The cable had to be cut using a clamp.Another device was obtained to complete the procedure; no patient injury occurred.Additional information regarding the procedure and intervention was requested multiple times, but not received.

• 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: 19323991
• Report Number: 9614641-2024-01099
• Device Sequence Number: 11415167
• Product Code: MND
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: CLASS2-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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: 17V
• Was Device Available for Evaluation?: No
• 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: 02/08/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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