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

Model Number HX-400U-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  malfunction  

Event Description

The olympus representative on behalf of the customer reported to olympus, the single use ligating device wire was cut after ligation, and it became impossible to operate.The issue was found during a diagnostic colonoscopy, the procedure was completed with a similar device and there were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed but could not be duplicated since the operation pipe had already been broken when sent back to olympus.The device evaluation found that the control part was damaged and fragmented due to mechanical loading, the operating pipe of the slider was broken and shaped as if it had been cut with a tool, and there was no loop attached to the hook (the loop was not returned).A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.A definitive root cause could not be established; however, based on the results of the investigation, it is likely that the wire being cut after ligation and becoming impossible to operate occurred due to: the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.The tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.An attempt was made to detach the loop in state of above description two therefore, the loop detached from the hook in the tube.While the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.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.Since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.The slider was forcefully operated in state of ¿6¿ description.This had caused the operating pipe to bend and to break.As for the operating pipe being broken, it is likely the following may have occurred: the sheath was bent near the handle.The operating wire could not move because sliding resistance between the sheath and the operating wire increased.The operating pipe deformed and broke because the slider was forcefully operated.Due to the above, the loop could not detach from the hook.It can be inferred that the sheath and handle were demolished by a tool for emergency measures.The following information is stated in the ifu (instructions for use) which may help to prevent the issue: ·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, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.·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 remove.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.·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 remove.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.·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.If additional information becomes available at a later date, this report will be supplemented.Olympus will continue to monitor field performance for this device.

Event Description

The device failed during the middle to end of the procedure, and there was a delay in the time it took to remove the loop, the time of the delay was not specified however.

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the customer:.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: 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: 17173652
• MDR Text Key: 318201271
• Report Number: 9614641-2023-00879
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 29K OR 33K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1