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

Model Number HX-400U-30

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

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

Event Date 04/11/2023

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

A company representative, on behalf of a user facility, reported that during a colonoscopy with a polypectomy using the single use ligating device, the loop was unable to release from the handle.The loop had been placed low around the stalk of a pedunculated polyp stalk (mushroom like) that was 30 cm into the colon.The instrument would not release from the hook and the white slider could not be pushed forward.The white handle broke and the silver slider broke off.As the loop was lodged around the stalk and could not be released, the endoscope could not be taken out of the patient.A gastroscope was placed perpendicular to the area in the colon, and a surgical/laparoscopic scissor was used to remove the polyp with an electrosurgical snare.After the item was removed, a hot snare was used to get the loop off of the stalk.Two clips were used to close the defect/cut area as there was bleeding.The procedure took an extra 90 minutes due to the complications and the patient required additional anesthesia.Additional information about the patient's outcome was requested but had not been received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Based on the evaluation of the subject device, the findings are as follows: the loop was connected to the device.The operation pipe of the handle was broken.The coil sheath was detached from the handle.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Although the specific day is unknown, it was determined that the subject device was manufactured in november 2020.Based on the results of the investigation, the root cause of the reported event could not be determined.However, the event was likely caused by the following mechanisms: mechanism 1: 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 the 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 bend and to break.Mechanism 2: 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 broke or deformed because the slider was forcefully operated.4) due to the above, the loop could not detach from the hook.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¿ 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¿ 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¿ 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.¿ this supplemental report includes a correction to d9, e3 and g2.Also, an update has been made to h3.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: b5, b7, d9, h3, and h6.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information indicated that the procedure was successfully completed, and the bleeding resolved with clips.The patient was currently doing well, as of the day of the report.

• 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: 16913588
• MDR Text Key: 315028899
• Report Number: 9614641-2023-00649
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2023
• 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: OYV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2023
• 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
• Treatment: UNKNOWN ENDOSCOPE
• Patient Outcome(s): Required Intervention