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

Model Number HX-400U-30

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reported during an endoscopic intestinal polypectomy procedure, the physician decided to use the ligating device to secure the clip tightly.After ligation, the loop could not be detached from the sheath.The customer presumed the spring of the release part of the handle was deformed and bent after use.Consequently, the sheath was successful detached from the loop with the use of forceps, and the procedure was completed.The device failure caused the procedure to be delayed for at least 1.5 hours.There were no reports of patient harm associated with this event.Additional details have been requested regarding the reported event.

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, although the root cause could not be determined, it is likely that the procedure was delayed because the loop could not detach from the sheath.Furthermore, from a past similar case, detachment fault of the loop was likely caused by the following mechanism: 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.The pulling of the tube sheath caused the loop to move with the distal end of the tube sheath toward the coil sheath.Subsequently, the loop entered the coil sheath and got caught between the hook and the coil sheath.The loop could not detach from the hook because got caught between the hook and the coil sheath.The slider was forcibly moved in the state of 4).This caused the operating pipe to break.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 in ¿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 be removed.In this case, refer to ¿emergency treatment¿ and as shown in ¿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 be removed.In this case ¿emergency treatment¿ and as shown in ¿equipment to be used in an emergency¿ 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; aomori, kuroishi-shi 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: 15271576
• MDR Text Key: 298385019
• Report Number: 9614641-2022-00176
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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: 15K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male