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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

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

Event Date 05/01/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the loop of the single use ligating device did not come off from the device after ligation during an unknown procedure.The physician had used all the loops out of the sheath.The insertion part was cut and the handle was detached, upon advice from the consultation center, and the loop came off.There was no harm or user injury reported due to the event.Additional information has been requested but no further information was obtained.

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.The operation pipe of the operation part was broken.The fracture part exhibited a ductile fracture shape.The coil sheath near the operating part was broken, and the broken part had a shape as if it had been cut with a tool.There was no loop attached to the hook and no loop was returned.There was no abnormality such as deformation or bending in the hook.There were also no other abnormalities related to the reported event.Since the actual product was damaged and the loop had already come off, the reported event could not be reproduced.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Correction to d4 udi.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation result, a likely mechanism causing the "difficulty removing the loop from the polyp" might be one of the following: 1) the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.2) the tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.3) an attempt was made to detach the loop in state of above description 2).Therefore, the loop detached from the hook in the tube.4) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.5) 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.6) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.7) the slider was forcefully operated in state of ¿6¿ description.This had caused the operation pipe to deform and to break. 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 or broke because the slider was forcefully operated.4) due to above, the loop could not detach from the hook.The root cause of the event cannot be specified.The event can be detected/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, 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 be removed.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 be removed.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." olympus will continue to monitor field performance for this device.

• 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: 17027955
• MDR Text Key: 316290077
• Report Number: 9614641-2023-00760
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 26K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 60 KG