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

Model Number HX-400U-30

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/21/2022

Event Type  Injury  

Event Description

A customer reported to olympus that during colonoscopy and removal of polyp, using this single use ligating device, the "wire connection" to the endo loop broke off at the handle, so that the endo loop could not be completely released.The polyp pedicle was cut below the endo loop using this single use electrosurgical knife.The bleeding in sequence was stopped using six through-the-scope (tts) clips and 3ml of purastat gel.The patient was monitored overnight, in the hospital, for post operative bleeding.No post operative bleeding, as reported.Case with patient identifier (b)(6) reports the single use ligating device used in the procedure.Case with patient identifier (b)(6) reports the single use electrosurgical knife used in the procedure.

Manufacturer Narrative

At this time, it is unknown if this device will be returned for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the insertion portion was severed near the handle.The operating pipe of the handle was deformed and broken.The rear end of the loop was not properly connected to the hook, and the loop was caught in between the coil sheath and the hook.The loop was pulled in the direction of the distal end.However, the loop could not be withdrawn from the coil sheath.The subject device was demolished to remove the loop from the coil sheath and deformation was observed in the rear end of the loop.However, the hook presented no abnormalities such as deformation or bending.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, a likely mechanism causing the reported event is as follows: 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 causing the operation pipe to bend and break.Furthermore, it is likely that the insertion portion was severed by a tool when removing the device from the body.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 ¿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 ¿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 ¿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.¿ this supplemental report includes information added to d4 and h4.Also, an update has been made to d9 and h3.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: 16219561
• MDR Text Key: 307882839
• Report Number: 9614641-2023-00095
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• 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: 14V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• 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: KD-620LR LOT 12K
• Patient Outcome(s): Required Intervention