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 Hemorrhage/Bleeding (1888)

Event Date 08/12/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The cause of the reported phenomenon could not be conclusively determined at this time.The investigation is ongoing, and if new and relevant information becomes available later, this report will be updated accordingly.

Event Description

Olympus was informed that during a polypectomy the poly loop failed to detach, leaving the device attached to the colonic mucosa.Another endoscope had to be used to detach the system.The patient suffered injury leading to hemorrhage that required blood transfusion.Additionally, the patient had to be intubated, assumedly as an urgent/unexpected medical intervention.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, the reported event was likely caused by the following: the loop was detached from the hook while the coil sheath was being retracted into the tube sheath, or the loop was hung on to the tissue and it was positionally fixed at the distal end of the tube.As a result, the loop was unable to release.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.Since the tube sheath was pulled toward the proximate side, causing the tube to pull the loop.This caused the loop to retract into the coil sheath.As a result, the loop was caught in between the hook and inner surface of the coil, and the loop stopped moving.The loop could not be detached from the device.Therefore, an emergency procedure was performed to remove the device from the patient¿s body.The tissue bled during the emergency procedure.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, ¿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, ¿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, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ in this manual.¿.This supplemental report includes new information regarding the event not previously reported.B2 and b5 have been updated to reflect the new information received from the customer.Also.A correction has been made to b3 and d8 from the initial medwatch.Olympus will continue to monitor field performance for this device.

Event Description

The following additional information was received: multiple attempts using a second colonoscope with a second column were required to remove the endo loop.As a result of the event, the patient required hospitalization in continuous care.

• 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, fukushima 961-8 061; JA 961-8061
• 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: 15925928
• MDR Text Key: 304918541
• Report Number: 9614641-2022-00710
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 14953170368612
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2022
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization