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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

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

Event Date 06/27/2023

Event Type  Injury  

Event Description

The olympus representative reported on behalf of the customer that during the polypectomy, the indwelling snare of the single use ligating device could not be released.The user performed the recommended emergency treatment and cut the slider with a nipper because it could not be released.The endoscope was removed and while the indwelling snare and coil sheath remained, the endoscope was reinserted and the polyp was resected.The snare and coil sheath were removed and the procedure was completed.There was no prolongation of the procedure and no harm to the patient.

Manufacturer Narrative

The device was not returned to olympus as it was discarded by the user.Therefore, the reported event could not be confirmed.Since the device lot number was unknown, the device history record (dhr) for the one year prior to the notification date was inspected.No abnormalities detected in the dhr related to the reported phenomenon.Based on the information available, it is not possible to identify the root cause of the reported event.However, a likely mechanism causing the reported event might be the following: 1) the sheath was bent near the handle.2) the operating wire could not move since sliding resistance between the sheath and the operating wire increased.3) the operating pipe deformed or broke since the slider was forcefully operated.4) due to above, the loop could not detach from the hook.The instruction manual contains the following description: ·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.·straighten out the portion of the instrument that extends from the biopsy valve.Olympus will continue to monitor the field performance of 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17396009
• MDR Text Key: 320036505
• Report Number: 9614641-2023-01036
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 WIRE CUTTERS
• Patient Outcome(s): Required Intervention