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 06/22/2022

Event Type  malfunction  

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 (3) reports to account the three devices failed that customer reported.Report with patient identifier (b)(6).

Manufacturer Narrative

The customer returned three (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 would not detach from the wire.Out of box failure.¿ these three (3) returned devices noted that - ( one (1) device ,the clip were closed upon being received, the other two (2) devices, the clip was already deployed upon being received ).For this device clip was deployed upon received - 1 of 2 device - a visual and functional inspection on the as is received condition of the devices performed.Evaluation observed that, the clip was deployed upon being received.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.Unable to perform a functional inspection as the clip has already been deployed.Investigation is ongoing.This report will be supplemented accordingly following investigation.

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 (dhr) found no deviations that could have caused or contributed to the failure of the device to clip.The dhr confirmed that the subject device was shipped in accordance with the specifications.A definitive root cause for this issue was not established.However, it is probable that the issue occurred because the clipping procedure, as specified in the device¿s instructions for use (ifu), was not completed.It was thought that a tensile force beyond the required resistance strength was applied to the area where the wire was secured in place.This may have caused the wire to detach from the operating portion.The following were identified as contributory factors: (a) the clip was pressed against an object, thus increasing the sliding resistance of the slider, and/or (b) resistance was likely increased because the area where the clip and the wire connect was buckled.Per the ifu, the following steps should be followed during the clipping procedure: ¿ set the endoscope in a model that simulates the digestive tract.Insert hx-201ur-135 into the endoscope.Bend the endoscope up to down 180° angle.(max).Move the slider forward and extend the connecting portion of the wire from the sheath.Press the clip against the silicon under the circumstances described above.Buckle the area where the clip and the wire are connected and keep pressing the clip.Pull the slider for clipping.¿ the occurrence of the reported problem can be prevented by adhering to the ifu which states the following: ¿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: 15171798
• MDR Text Key: 304897358
• Report Number: 9614641-2022-00114
• 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: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• 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: 08/01/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2021
• 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