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

Model Number HX-400U-30

Device Problem Separation Failure (2547)

Patient Problems Perforation (2001); Foreign Body In Patient (2687)

Event Date 07/05/2022

Event Type  Injury  

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.

Event Description

The customer reported to olympus, during the therapeutic procedure, the subject device ligator would not release from the polyp.The surgeon attempted to release the subject device with a loop cutter but was unsuccessful.The procedure was completed and the subject device was left in the patient.Two days after this procedure, the patient had a second procedure to remove the subject device ligator by burning off the coil sheath with a non-olympus device but still could not release the ligator.The surgeon attempted to release the ligator several times but could not release and a perforation occurred in the surrounding mucous membrane.A cat scan was performed and the patient was immediately transferred and fitted with an artificial anus.

Manufacturer Narrative

This supplemental report is being submitted to provide the results of the legal manufacturer¿s investigation and the results of the device history records (dhr) review.New information added to the following fields: h3, h6, h10.The device evaluation findings included: the coil sheath was cut at 495 mm and 980 mm from the tip side, tube sheath was not sent, loop was built in, loop stopper had moved to the tip side, loop stopper was caught on the coil sheath, control pipe of the actuator was broken, and broken surface of the coil sheath showed a broken shape caused by a tool.H4: manufactured on march, 2022 based on the provided 3 digit lot information the dhr for this device were reviewed and all records indicated the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.A definitive root cause was not identified.Based on the available information, the legal manufacturer determined the probable cause of the failure is likely due to the following: ·the proximal side of the loop was temporarily pulled into the coil sheath, and the loop was caught between the coil sheath and the hook.By forcibly operating the slider in this state, the operation pipe was bent and broken.Above phenomenon was caused by the following mechanism: 1) the loop was unhooked while the coil sheath was pulled into the tube sheath.Alternatively, the operator unhooked the loop from the hook while the loop was hung on the tissue and fixed at the tip of the tube sheath.2) the tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.3) the tube sheath was pulled in the proximal direction causing the tube to pull the loop.This caused the loop to retract into the coil sheath.As a result, the loop and the hook became intermeshed.This prevented from smooth movement.4) the operation pipe was damaged by forcibly operating the slider in the state of 3).As a result of checking the instruction manual, the following description related to this event was identified do not step on, pinch, or hit the coil sheath during use.Doing so may cause the coil sheath to collapse, deform, or buckle, and after tying, the hook may get caught inside the coil sheath and prevent the loop from coming off.Before use, make sure that the entire coil sheath is not crushed, bent or deformed, and do not use this product if the coil sheath is abnormal.In the unlikely event that the loop becomes stuck during use, see ¿emergency preparation¿ and ¿12 emergency procedures¿ on page 3.Do not remove the loop from the hook while the coil sheath is pulled into the tube sheath.The loop may become entangled in the hook and may not be removed from the product.In the unlikely event that the loop becomes stuck during use, see ¿emergency preparation¿ and ¿12 emergency procedures¿ on page 3.Do not fix the loop with the tip of the tube sheath while the loop is hung on the tissue.If the loop is removed from the hook in this state, the loop may come off inside the tube sheath and become entangled in the hook, preventing it from being removed from the product.In the unlikely event that the loop becomes stuck during use, see ¿emergency preparation¿ and ¿12 emergency procedures¿ on page 3.Do not use excessive force to operate each part.Doing so may damage the product.The instruction manual was reviewed.They include the following descriptions associated with the reported phenomenon.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.

• 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: 15164571
• MDR Text Key: 297244638
• Report Number: 9614641-2022-00108
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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: 23K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• 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: MAJ-665, UNK LOT; PCF-H290ZI, UNK SERIAL
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 92 YR
• Patient Sex: Male