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 10/11/2022

Event Type  malfunction  

Event Description

The customer reported the subject device malfunctioned during an a therapeutic endoscopy procedures.It was reported, once the loop was secured on the base of the polyp, the wire inside the device broke at the level of the handle and it could not be removed.The nurses were able to take the handle apart and were able to eventually release it and remove it from the patient and the scope.There was an unspecified delay in the procedure and the intended procedure was successfully completed.

Manufacturer Narrative

The suspect device has not been returned to olympus for evaluation.The investigation is in process.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: olympus was unable to perform a functional test on the subject device due to the damaged operating wire and cut insertion portion.The coil on the insertion portion was heavily stretched and the yellow tube joint was detached prior to being received.The operating wire within the handle section was cut and protruding outwards.The following defects were noted: the operating pipe was broken near the distal end of the handle, the operating pipe in the handle was broken, the tube joint portion was detached from the device, the coil was frayed and stretched at the proximal side of the coil sheath, and the condition of the loop and hook could not be confirmed a review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, a likely factor that caused the reported event was that the proximate side of the loop was temporarily retracted into the coil sheath, and the loop was caught in between the coil sheath and the hook.This prevented the slider from moving and the loop could not be detached from the coil sheath.Under these circumstances, the slider was forcefully operated.As a result, the operating pipe was bent and broken.Detachment fault of the loop was likely caused by the following mechanism: 1.The loop was detached from the hook while the coil sheath was being retracted into the tube sheath, or the loop was hung on to the tissue and it was positionally fixed at the distal end of the tube.As a result, the loop was unable to release.2.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.3.Since the tube sheath was pulled toward the proximate side, causing the tube to pull the loop.This caused the loop to retract into the coil sheath.As a result, the loop was caught in between the hook and inner surface of the coil, and the loop stopped moving.4.The slider was forcefully operated in state of ¿3¿ description.This had caused the operation pipe and to break.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 ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ 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 ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ 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 ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿ ¿never use excessive force to operate the instrument.This could damage the instrument.¿ this supplemental report includes a correction to d4 (lot number) from initial medwatch.Also, additional information was added to d9, h3 and h4.Olympus will continue to monitor field performance for this device.

Event Description

The customer provided additional information regarding the event: - the intended procedure was a colonoscopy with polypectomy.The loop was on and secured, and they were at the point of releasing the loop when the issue occurred.The rest of the colonoscopy had already been completed.The customer reported a delay of about 20 minutes while figuring out how to get the loop out of the scope and the patient.The device was removed from a sealed package and everything looked to be intact prior to use.- the facility used wire cutters to cut the wire, split the wire and then had to remove the plastic and uncoil it.Then they were able to push the wire in.They had already cut the polyp but there was a stem left and dr.Xue decided to use the loop because he was worried about bleeding.

Manufacturer Narrative

This report is being supplemented to provide additional information obtained from the customer.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report includes a correction to h6 code (investigation findings).Code 114 (operational problem identified) added to h6, as it was inadvertently not included on the previous submission.

• 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15758572
• MDR Text Key: 307110840
• Report Number: 9614641-2022-00579
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup,Followup,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• 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 14
• 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: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2022
• 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: UNKNOWN COLONOSCOPE, SERIAL NUMBER (B)(6).; UNKNOWN ENDOSCOPE.