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

Model Number HX-400U-30

Device Problem Mechanical Problem (1384)

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

Event Date 09/01/2021

Event Type  malfunction  

Event Description

The physician reported that during a colonoscopy the single use ligating device was difficult to detach loop from the polyp loop.The procedure was prolonged due to the malfunction of the device; however, there was no patient injury reported due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.

Manufacturer Narrative

The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.Based on the results of the investigation, a definitive root cause could not be determined as the suspect device was not returned for evaluation.The contents of the instruction manual warns as follows: 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.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.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.Never use excessive force to operate the instrument.This could damage the instrument.The suspect device was not returned for evaluation.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the user facility regarding the reported event (see b5).

Event Description

There was difficulty detaching the loop from the sheath.The polyloop was discarded.There was a 10 minute delay in the procedure.There were no adverse effects to the patient as a result.Emergency maneuvers (as described in the ifu) were required to free the device from the patient.The colonoscopy was completed successfully with a second device.The patient's current condition is "fine".The model and serial number for the scope used in the procedure is unknown.No images of the suspect device can be provided, the device was destroyed.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 01-sept-2021.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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: 13934219
• MDR Text Key: 288128306
• Report Number: 8010047-2022-05160
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• 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