MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problem Failure to Eject (4010)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

The customer reported that, when closing the loop during a colonoscopy and polypectomy, the loop could not be released.The wire the loop sits on was broken and the spring had come out.Another nurse was called to assist and was able to release the loop by moving below the handle and pulling back again three times.The loop had stayed in position, so no further intervention was necessary.There was no harm or user injury reported at the time.The patient later reported some pain and was referred to seek treatment for the pain.

Manufacturer Narrative

The subject device was not returned to olympus.Therefore, the reported phenomenon and condition of the device could not be confirmed.Since the device lot number was unknown, the device history record (dhr) for the six months prior to the date of occurrence was inspected.No abnormalities were detected in the dhr for the items which related to the reported phenomenon.Since no abnormalities were detected in the dhr, it is inferred that the subject device did not have abnormalities.Based on the results of the legal manufacturer's investigation, it is likely the loop was not detached from the distal end of the device due to the following: an attempt was made to detach the loop from the hook under the following circumstance which caused the loop to detach from the hook inside the tube sheath.The loop was hung on to the tissue, and it was fixed at the distal end of the tube sheath.The tube sheath was pulled towards the proximal side while the hook was extended from the distal end of the coil sheath.Since the tube sheath was pulled towards the proximal side, the tube pulled the loop, and the loop was retracted into the coil sheath.As a result, the loop was caught in between the hook and inside the coil.This prevented the loop from moving.The slider was forcefully operated in this state and the spring protruded from the handle.Upon operating the slider, the loop detached from the hook.As a result, the loop was released from the hook.Due to mechanism described above, the tissue that was ligated with the loop was stimulated.Therefore, the patient felt pain.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warnings, which may help to prevent the issue: "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." 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14852654
• MDR Text Key: 302589078
• Report Number: 8010047-2022-11007
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/15/2021
• 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