MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problem Entrapment of Device (1212)

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

Event Date 10/08/2021

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The definitive cause of the user's experience cannot yet be determined.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

It is reported during a colonoscopy using a single use ligating device and a colonoscope, the release mechanism malfunctioned and did not deploy as the inner wire broke on attempted deployment.The endoloop remained attached to the polyp base.The physician tried to remove the scope but could not because it was pulling on the large polyp.The physician used a wire cutter to cut below the handle, the sheath was stripped, and the outer coil cut with attempt to manipulate the inner wire or the outer coil with no improvement.The doctor could not determine what was preventing the scope from being removed after the handle was already cut as outlined in the instruction manual¿s emergency procedure.The physician called olympus emergently for potential injury.Troubleshooting steps failed.Olympus advised there is the possibility of open surgery being required to remove the retained endoloop/scope.The physician employed the use of a second endoscopy scope and tower and performed a colonoscopy adjacent to the tethered scope and endoloop.Using cutters, the physician was able to manually cut the endoloop to free up the first endoscope and remove the endoloop wire and sheath that was previously tethered.There was no injury to the patient during these maneuvers, however the case was prolonged and required significant technical effort.The patient's current condition is described as: there was no injury to the patient.The colonoscope did not malfunction in any way.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device was reviewed and it was determined the device met all accordance with all design and safety specification when it was shipped.The instructions for use (ifu) shipped with the device provides the user the following information related to the reported event: ·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.Conclusion summary: the definitive cause of the reported events could not be established.·the device was not retuned for the investigation.It is presumed this issue was not caused by a device issue as no abnormalities were found in the device history record.Based on historical assessment of similar reports, detachment fault of the loop was likely caused by the mechanism below.1) 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.(fig.1) 2) the tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.3) 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.(fig.2).

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12739455
• MDR Text Key: 279630361
• Report Number: 8010047-2021-13976
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• 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: OXV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/27/2022
• 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
• Treatment: PCF-H190DL, (B)(6); PCF-H190DL, (B)(4).
• Patient Outcome(s): Required Intervention
• Patient Age: 25 YR
• Patient Sex: Male
• Patient Weight: 73 KG