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

Model Number HX-400U-30

Device Problem Mechanical Jam (2983)

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

Event Date 01/24/2022

Event Type  malfunction  

Event Description

The customer reported that the physician was unable to ligate a polyp with the device during a procedure.The slider on the proximal side could not be pulled.The physician also could not press the slider to open the loop further.A loop cutter was used to the break the loop.Another ligating device was used to complete the procedure.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.There was no harm or user injury reported due to the event.

Manufacturer Narrative

The suspect device was returned to olympus.Inspection and testing showed evidence of the loop being cut.There were no abnormalities such as deformation or bending of the hook and no other abnormalities that could lead to the reported event.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Customer confirmed it was a therapeutic colorectal polyp resection procedure.

Manufacturer Narrative

This report is being supplemented to provide additional information received from the customer and g3 correction.Correction to g3 of the initial medwatch.The aware date should be 31-jan-2022.B5 - updated with information received from the customer.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, possible causes may include: 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.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.A definitive root cause cannot be identified.This issue is covered in the instructions for use: the instruction manual contains the following descriptions, and it warns against this event.(gk8332 rev.04).·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 the field performance of 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: 13934652
• MDR Text Key: 297888472
• Report Number: 8010047-2022-05176
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 14K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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: FS-5Q-1: OLYMPUS LOOP CUTTER.