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

Model Number HX-400U-30

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 03/28/2023

Event Type  Injury  

Event Description

The customer reported to olympus that the single use ligating device was difficult to detach and the handle broke.The handle was cut off manually with side cutters.The endoscope was removed, reinserted, and the loop was removed with forceps.The issue was found during an unidentified procedure.There were no reports of patient harm.

Manufacturer Narrative

The suspect device has not been returned to olympus at this time.Additional information has been requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information as reflected on b5.The suspect device has been returned to olympus, but the physical evaluation has not yet begun.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

Additional information was received from the customer.The procedure performed was a therapeutic polypectomy of a pedunculated polyp.The procedure was completed with a different device after an unspecified delay.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, evaluation and corrections to the initial with information inadvertently left out.A portion of the device was returned to olympus for inspection, and the customer's complaint/reportable malfunction was confirmed.The subject device was manufactured in june 2020, but the specific date is unknown.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, it is likely the phenomenon occurred due to one of the following: 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.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 operation pipe to bend and to break. 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 or broke because the slider was forcefully operated.4) due to above, the loop could not detach from the hook.However, the root cause of the phenomenon could not be identified.It was determined that the parts near the handle was destroyed by a cutter for an emergency measure.However, the root cause of the phenomenon could not be identified.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.·straighten out the portion of the instrument that extends from the biopsy valve." in addition, the following non-reportable malfunctions were found during the device evaluation: the operating wire had been removed from the coil sheath, the coil sheath was severed at approximately 2250 mm from its distal end, the tube sheath was severed at approximately 2240 mm from its distal end, the coil sheath was missing approximately 50-60 mm, the tube sheath was missing approximately 26.7-29.5 mm, the parts on the root side of the handle were destroyed, the handle was broken, the operation pipe was broken, and the broken portion of the operation pipe had the characteristic shape that appear in ductile fracture.Additionally, the loop was not connected to the hook, and not returned for investigation.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: 16828481
• MDR Text Key: 314161038
• Report Number: 9614641-2023-00575
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 06V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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