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

Model Number HX-400U-30

Device Problems Mechanical Problem (1384); Separation Problem (4043)

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

Event Date 09/14/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was received and evaluated.The loop was not sent with the product.The product was hx-400u-30.The lot number was 22k and the supplemental information was "14" (product manufactured on february 14, 2022).The tube sheath had buckled at approximately 115 mm from the base of the actuator.Device evaluation includes testing of the device by attaching a reference loop (olympus loop from the inventory) to the hook of the actual product and was found able to be attached without any problem.The loop did not come off the hook when the tip of the coil sheath was shaken.When the slider was pushed to push the hook out of the coil sheath, the loop detached from the hook without any problem.There was no deformation or bending of the hook.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

It was reported during an unspecified procedure, the ligating device sheath operation was noted to be heavy and the doctor could not release it well.According to the reporter, the doctor was then managed to release however, it was an incomplete ligature.The site was the sigmoid colon and no information provided on the endoscope used.The reporter stated that the procedure was completed as it is without replacing the equipment.There was no patient harm , no adverse event reported due to the event.No user injury reported.This report is being submitted for ligating device issue (difficult to detach loop -could be detached according to the instruction manual).

Manufacturer Narrative

This report is being supplemented to provide additional information provided by the reporting person and additional information based on the legal manufacturer's final investigation.The medical staff inspected the subject device before the procedure, and there was no problem with the appearance of the device.Therefore, it is likely that the user was frantically operating the slider since the device could not work.This might have caused the sheath to buckle.It is inferred that the sheath buckling occurred from the state without buckling.It is possible that temporary ligating was performed by using the subject device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.Based on the results of the legal manufacturer's investigation, it is likely 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 smoothly and the loop could not be detached from the coil sheath well.The above phenomenon occurs by the following mechanism: 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, 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.However, a definitive root cause could not be determined.The following information is stated in the ifu (instructions for use) which may have prevented the event: -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.-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.-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.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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15584603
• MDR Text Key: 307169809
• Report Number: 9614641-2022-00454
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• 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: 22K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2022
• 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
• Treatment: UNKNOWN ENDOSCOPE