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 11/21/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been received by olympus for evaluation.The evaluation is not yet complete.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during a polypectomy procedure using a single use ligating device, the tissue was bound.The loop was not released and could not be removed from the sheath.The user cut the wire of the loop with a loop cutter per the instructions for use (ifu).The tissue was then excised using a separate high frequency snare.The procedure was completed with this second device with no health hazard to the patient.

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 findings are as follows: the loop was not connected to the device, and not returned for investigation.The distal end of the tube sheath was deformed and had some holes.The operating pipe of handle was deformed and broken.The hook portion was able to operate by moving the broken operating pipe back and forward.The hook presented no abnormalities such as deformation or bending.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, a likely factor causing the reported event is as follows: 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.Detachment fault of the loop was likely caused by the following mechanism: 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.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.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.This had caused the operating pipe to bend and break.Furthermore, it is likely that the tube sheath was deformed and damaged during the emergency measures to detach the loop.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, 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.¿ this supplemental report includes a correction to g2 to provide information that was inadvertently not included on the initial medwatch.Also, an update has been made to h3.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 (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16014817
• MDR Text Key: 305807027
• Report Number: 9614641-2022-00804
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• 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: 26K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2022
• 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
• Patient Outcome(s): Required Intervention