MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ROTATABLE CLIP FIXING DEVICE

Model Number HX-201UR-135-A

Device Problems Separation Failure (2547); Activation, Positioning or Separation Problem (2906)

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

Event Date 07/01/2022

Event Type  malfunction  

Manufacturer Narrative

The customer returned 3 single use rotatable clip fixing device model number hx-201ur-135-a , lot number 17v 01 for the evaluation quick clips would attach to tissue but wouldn't detach from the wire.Out of box failure.Visual inspection noted: these three returned devices noted - one device, the clip on the device has been deployed, the other two devices, clip still attached.Note: as for the 2 other devices, both clips were closed upon being received/clip still attached.A visual and functional inspection on the as is received condition of the devices performed.There are no sharp protrusions or edges on the distal end of the insertion portion of these devices.The entire length of each insertion portion inspected and verified there were no crushed, bends, or broken areas.The handle portion appears to have no cracks or discrepancies.Performed a functional inspection in attempting to deploy the clip and was unsuccessful (this is for the device where the clip still attached.1of 2.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported an out of box failures for three hx-201ur-135-a device with lot number 17v 01.Device was reported to fail upon initial use (therapeutic).The quickclips would attach to tissue, but would not detach from the wire.There was no patient harm or injury reported due to the event.No user injury reported.This event includes three reports to account the three devices failed that customer reported.Report with patient identifier (b)(6).Report with patient identifier (b)(6).Report with patient identifier (b)(6).This report is for patient identifier (b)(6).

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was manufactured in july 2021.However, the specific date is unknown.Based on the results of the investigation, the definitive root cause of the detachment issue could not be determined.It is possible that a tensile force beyond the resistance strength was applied to the area where the wire was secured in place, which caused the wire to detach from the operating portion.It is also possible that the clip was pressed against an object, which increased the slider's sliding resistance.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿should the slightest irregularity and/or breakage of the parts be suspected, withdraw the instrument from the endoscope immediately according to the steps of ¿withdrawing the instrument from the endoscope¿ on page 10.Otherwise, perforation, bleeding, or mucous membrane damage may result¿.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Type of Device: SINGLE USE ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 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: 15161619
• MDR Text Key: 302727471
• Report Number: 9614641-2022-00101
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 04953170353123
• UDI-Public: 04953170353123
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-201UR-135-A
• Device Lot Number: 17V 01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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