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

Model Number HX-400U-30

Device Problem Failure to Disconnect (2541)

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

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus for evaluation, and the root cause could not be identified.The results are as follows: the sheath was severed at approximately 1680 mm from the distal end of insertion portion.The loop was attached to the device.The distal end of the loop was severed.Condition of the connection between the loop and the hook was inspected by stretching the coil sheath.The rear end of the loop was not properly connected to the hook, and the loop was caught in between the coil sheath and the hook.The subject device was demolished to remove the loop from the coil sheath.The rear of the loop was deformed.The hook presented no abnormalities such as deformation or bending.Other abnormalities that could lead to the reported event were not confirmed.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, the mechanism that likely caused the reported event is as follows: 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 2).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.It can be inferred that the loop was severed by a loop cutter for emergency measures.It can be inferred that the sheath was severed by a tool for emergency measures.The event can be detected/prevented by following the instructions for use (ifu) 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.Olympus will continue to monitor field performance for this device.

Event Description

The customer reported to olympus that during colonoscopy, after ligating a polyp using an indwelling snare, the single use ligating device did not come off.Following the instruction manual, it was removed using a loop cutter and the procedure was completed by switching to the same product.No health hazard to patient, as reported.The nurse mentioned that it is possible that the coil sheath was ligated without protruding from the tube.There were no reports of patient or user harm associated with this event.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17132146
• MDR Text Key: 317208343
• Report Number: 9614641-2023-00847
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• 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: 27K05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2022
• 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
• Treatment: PCF (MODEL NUMBER UNKNOWN) - LOT/SN UNKNOWN
• Patient Outcome(s): Required Intervention