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

Model Number HX-400U-30

Device Problem Break (1069)

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

Event Date 11/01/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the single use ligating device was impossible to release the endoloop which remained open and blocked in the endoscope.It was finally release in the patient.Opening of a second endoloop which remained tight at the level of the foot of the polyp, forced to break the handle to release the loop.The issue occurred during a gastroenterology polyp ligation.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus but has not yet been evaluated.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 (h6/h10), device evaluation (d9/h3/h6/h10), to correct a2/a3/d4/e2/e3/g2 (information inadvertently missed on the initial), to correct h8 (single use device), to correct h10 (provide reference for second issue), and to update h4.Correction to h10: the devices with endoloop issues are captured in the medwatches below: patient identifier model number serial number (b)(6).This medwatch is for patient identifier: (b)(6).A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was returned to olympus for inspection, and the customer's complaint was not confirmed as the the loop was not attached nor returned with the device.There was no damage to the handle.The hook could protrude smoothly when the slider was pushed.An aomori olympus¿s loop was able to attach to the hook of the subject device without any problems.When the slider was pulled the loop was able to tie up an object and when pushed it released from the hook without issue.The hook presented no abnormalities such as deformation or bending.Based on the results of the investigation, the root cause could not be determined.It is likely the event was caused by 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 when the coil sheath was in the tube sheath (mentioned above).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 with the loop and hook stuck together.This had caused the operation pipe to bend and to break.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." "·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." 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: 15946111
• MDR Text Key: 308349666
• Report Number: 9614641-2022-00739
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 14953170368612
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 24V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2022
• 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
• Patient Age: 59 YR
• Patient Sex: Male