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

Model Number HX-400U-30

Device Problem Separation Problem (4043)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

The customer reported to olympus, the single use ligating device would not come off the body easily when ligated.When pushed and pulled the slider at hand several times, the wire in the slider part was broken.Finally, the loop came off the body.Using similar equipment, the ligation before tumor resection procedure was completed.No broken wire fragments fell within, nor remained within, the patient.The procedure time was delayed by 5 minutes because the loop did not come off smoothly.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found the polyp-loop was able to be detached according to the instruction manual.Addition findings include the operating pipe was broken; the investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is received.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, it¿s probable the sheath and handle were demolished by a tool for emergency measures.Although a definitive root cause cannot be identified, the following mechanisms likely caused the event (difficult to detach loop from polyp-loop): mechanism 1: 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 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.(see fig.5) 6)since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.7)the slider was forcefully operated in state of ¿6¿ description.This had caused the operating pipe to bend and to break.Or mechanism 2: 1)the sheath was bent near the handle.2)the operating wire could not move because sliding resistance between the sheath and the operating wire increased.3)the operating pipe deformed and broke because the slider was forcefully operated.4)due to above, the loop could not detach from the hook.The following is included in the instructions for use: ¿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.Straighten out the portion of the instrument that extends from the biopsy valve.¿ 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: 17307400
• MDR Text Key: 319236455
• Report Number: 9614641-2023-00974
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• 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: 06/20/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2023
• 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