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

Model Number HX-400U-30

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/07/2022

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 a therapeutic colonoscopy, the subject device was inserted into the endoscope to encircle the foot of the polyp and when trying to release the device, the spring of the sliding handle broke and released.The system could not be unlocked to detach the loop.A second endoscope was inserted to release the loop with a polpectomy loop by resecting the foot of the polyp.The patient was started on antibiotics.It is unknown how the patient is doing today.There was a twenty-five minute delay due to the malfunction and the patient was under general anesthesia.

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 following was observed: the coil sheath was slightly deformed at approximately 60 mm from the distal end.Misalignment of the coil was observed between approximately 110 mm and approximately 115 mm from the distal end of the handle.The operating pipe of the handle was deformed and broken.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the coil sheath and the hook.The loop was pulled in the direction of the distal end.However, the loop could not be withdrawn from the coil sheath.The subject device was demolished to remove the loop from the coil sheath.The loop stopper was not attached to the loop.Appearance of the loop was inspected.Deformation was observed in the rear end of the loop.The hook presented no abnormalities.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been more than 2 years since the subject device was manufactured.Based on the results of the investigation, a likely factor causing the reported event is likely the following: 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.Furthermore, detachment fault of the loop was likely caused by the 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.The slider was forcefully operated in state of ¿3¿ description causing the operation pipe to bend and 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 ¿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¿ on page 3 in this manual.¿ ¿never use excessive force to operate the instrument.This could damage the instrument.¿ this supplemental report includes information added to d9, h3 and h4.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: 15536225
• MDR Text Key: 301098892
• Report Number: 9614641-2022-00405
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• 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
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• 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: V0321
• 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: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2020
• 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; Other