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

Model Number HX-400U-30

Device Problem Mechanical Problem (1384)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.Upon inspection as received, one loop was broken, and one loop was off the hook.When testing the device, the slider operated smoothly, and the hook was able to ligate and release the loop without any problems.No abnormalities were visualized on the hook.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

The customer reported that during an endoscopic mucosal resection (emr) of the large intestine procedure using the single use ligating device, there was a feeling that the root of the loop was pulled into the endoscopic channel while pulling the slider of the product.The operation was continued, and the tissue was ligated, but the hook could not be removed from the loop.The same type of product was used after cutting the loop using a loop cutter guided to the ligation site according to the emergency procedure described in the instruction manual to remove the product from the tissue.The procedure was completed without injury to the patient.

Manufacturer Narrative

The aware date should be 28-jan-2022.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the investigation confirmed one loop to be broken and one loop to be off the hook.The specific root cause of the broken loops could not be determined at this time.Although a definitive root cause cannot be identified, the following step-by-step scenario likely caused the event: 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, the loop pulled the tube.This might have caused the loop to be retracted into the coil sheath.As a result of actions stated above, the loop was caught in between the hook and inner surface of the coil, and the loop stopped moving.The event can be prevented by following the instructions for use 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 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): 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: 13934598
• MDR Text Key: 297880090
• Report Number: 8010047-2022-05170
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/19/2022

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: 12K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2021
• 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