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 Foreign Body In Patient (2687)

Event Date 06/28/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a single use ligating device, the loop could not be detached after ligation.The physician had to cut out the line and remove it together with the scope.A new scope was re-inserted with a cutting device to cut the loop and remove the remaining device section from the patient.No further consequences to the patient have been reported.Additional information has been requested.At this time, no additional information has been provided.From this event, the physician has lost his trust and faith in the entire product lot and is returning the lot for credit.

Manufacturer Narrative

The device referenced in this report has been received by olympus.Preliminary physical observations are provided below.The comprehensive device evolution has no yet be completed.The investigation is ongoing, this report will be updated upon completion of the investigation or upon receipt of additional relevant information.The received condition of the suspect device: olympus received 2 devices, one in unused condition and the second was received in a used/destructed condition with the poly-loop and coil sheath cut.

Manufacturer Narrative

This report is being updated to provide additional information reported by the customer.New information is reported id b5, d10.

Event Description

Update: additional information provided by the customer.The scope used in the procedure did not malfunction.The patient did not require any treatment/intervention.

Manufacturer Narrative

H4: the subject device was manufactured on july, 2019 based on the provided 3 digit lot information.The exact manufacture date could not be identified as the part indicating the lot number was not returned.This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The subject device was evaluated where the following was noted: - the loop was attached to the subject device.The distal end of the loop was severed.- the loop stopper was detached from the loop.- the coil sheath and the tube sheath were severed near the handle.- the handle was separated from the insertion portion.- the operating pipe in the handle was broken.No buckling was observed in the coil sheath.- when moving the operating wire, the loop could extend and retract smoothly as intended.- the loop was connected to the hook without any problems.- no deformation was observed in the rear end of the loop.- the hook presented no abnormalities such as deformation or bending.The unopened device returned by the customer was also evaluated and functional testing performed where: product: hx-400u-30.Lot number: 97 k.Supplementary information: 10.A metal bar with the outer diameter of 6.0 mm was tied down and the slider was pressed.The loop was able to release from the hook without any problems.Also, there were no abnormalities in the force for the loop to release.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the investigation result and the investigation results in the past, a likely mechanism causing the loop not being able to release from the hook is likely the following: 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 broke or deformed because the slider was forcefully operated.4) due to above, the loop could not detach from the hook.It has been confirmed that the breakage of the operating pipe could replicate by the following mechanism: 1.The coil sheath was bent at approximately 2-3 cm from distal end of the handle.2.In the state of ¿1¿, the slider was pushed/pulled repeatedly.3.The operating pipe was bent and broken.The following is included in the instructions for use (ifu): "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.

• 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: 15104471
• MDR Text Key: 296596667
• Report Number: 9614641-2022-00034
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2022
• 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: 97K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/06/2022
• 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
• Treatment: CF-HQ190L; UNSPECIFIED SCOPE
• Patient Outcome(s): Required Intervention; Other