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 06/26/2023

Event Type  Injury  

Manufacturer Narrative

Upon evaluation of the returned device, it was confirmed that the loop was stuck and unable to be released.The tube sheath was sent with a broken tube sheath of about 460 mm and a coil sheath of about 480 mm from the tip of the insertion part.The remaining sheath and controls were not sent.The break of the coil sheath was shaped as if it had been cut with a tool.The loop was retracted into the coil sheath and was sandwiched between protruding hooks and it was unable to be pulled out due to strong resistance.When the actual product was destroyed and the loop was pulled out, it was found that about 55 mm was drawn into the coil sheath from the rear end of the loop.There was no noticeable deformation at the rear end of the loop.The loop tip had been cut.There were no abnormalities such as deformation or bending on the hook.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

An olympus representative reported to olympus on behalf of the customer that during an unspecified surgery, the ligation loop did not come off when it was snared and attempted to be removed from the hook.The sheath wire was cut, the scope was removed, and the snare loop was cut with a loop cutter.The procedure was cancelled.There was no harm or user injury reported due to the event.

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, the root cause could not be determined.However, the reported event (difficulty removing the loop from the polyp) likely occurred due to the following mechanism: 1) the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.2) the tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.3) an attempt was made to detach the loop in the state of above description 2).Therefore, the loop detached from the hook in the tube.4) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.5) the hook was pulled.This caused the hook and the loop to retract into the coil sheath together.As a result, the loop and the hook got stuck inside the coil and could not move.6) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.Furthermore, it was determined that the sheath was severed by a tool as an emergency measure.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 section 12, ¿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 remove.In this case, refer to section 12, ¿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 remove.In this case, refer to section 12, ¿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): 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: 17414714
• MDR Text Key: 320033455
• Report Number: 9614641-2023-01045
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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