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

Model Number HX-400U-30

Device Problem Failure to Unfold or Unwrap (1669)

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

Event Date 10/31/2022

Event Type  malfunction  

Event Description

An olympus employee reported on behalf of the customer, a doctor could not release the single use ligating device.It was exchanged for another device, but it was unable to be released as well.The third device was able to be released and the unspecified therapeutic procedure was completed.There was no patient harm associated with this event.Event 2 of 2 this report is being submitted for the issue with the second single use ligating device, under medwatch with patient identifier (b)(4).The issue with the first single use ligating device is being reported on the medwatch patient identifier (b)(4).

Manufacturer Narrative

Two subject devices were returned to olympus for evaluation.There was no indication which device was associated with which patient identifier.During inspection and testing, the allegations of not releasing were confirmed.On the first device the operating pipe and the operating wire of the handle were broken.The loop was severed at the distal end.No buckling was observed in the coil sheath.Condition of the connecting area between the hook and the loop was inspected by stretching the coil sheath.The loop was attached to the hook without any problems.The operating wire was pushed by severing the insertion portion, allowing the loop to protrude smoothly, and detach from the hook.The rear end of the loop did not present any deformation.There were no abnormalities such as deformations or bending observed on the hook.No other abnormalities that could lead to the reported event could not be confirmed.On the second device the operating pipe of the handle was deformed.No buckling was observed in the coil sheath.The operating wire was pushed by severing the insertion portion, allowing the loop to protrude smoothly, and detach from the hook.The rear end of the loop did not present any deformation.There were no abnormalities such as deformations or bending observed on the hook.No other abnormalities that could lead to the reported event could not be confirmed.A review of the device history record (dhr) found no deviations that could have caused or contributed to the reported device problem.The dhr confirmed that the subject device was shipped in accordance with the specifications.The investigation concluded the probable mechanism causing the reported event, was likely at the root of the handle, an attempt was made to release the loop by pushing the slider with the bent coil sheath.Due to this motion, the operating pipe was stuck at a bent area of the coil sheath.Force to push the slider was applied to the operating wire that was stuck, and the operating handle was pressed causing a deformation.After the operating pipe became deformed, the slider was pushed and pulled continuously.This caused the deformed operating pipe to break.The operating pipe was either deformed or broke, and the slider could not be operated.As a result, the loop could not be detached the instruction manual provides the following regarding proper use of the device: ¿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.¿ olympus will continue to monitor field performance for this device.Additional information has been requested regarding this event.A supplemental report will be submitted if additional information becomes available.

Manufacturer Narrative

Additional information has been received from the customer.This supplemental report is being submitted to provide this information.Please see the update in section b5.

Event Description

The customer provided additional information: the intended procedure was to ligate polyp, no other device was involved, and the type of sedation is unknown.

• 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: 15894257
• MDR Text Key: 308010848
• Report Number: 9614641-2022-00686
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• 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: 28K05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2022
• 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