MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE RELOADABLE CLIP APPLICATOR

Model Number	HX-810UR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified therapeutic procedure, the clip could not release and the wire came lose while setting up the clip.Additionally, the complete charge 2yk was affected.There was no report of patient harm.This mdr is being submitted to report one of the three clip applicators used during the reported event.This report is linked to the following patient identifiers: (b)(6) which represents each failed clip during the procedure.(b)(6) representing the other two clip applicators used during the procedure.
Additional Manufacturer Narrative
The device was not returned to olympus, and is not expected to be returned for evaluation of the reported issue.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information obtained regarding the event and results of the final investigation.The device was manufactured in november 2022, but the specific date is unknown.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, and since the device was not returned, the exact cause could not be identified.From the results of the reproduction study in the past, the load exceeding the tolerance was applied to the device and it is likely the event occurred by the following mechanism: 1.Due to some influence during clipping, the amount of operating force increased.2.An excessive tensile load was applied to the operating wire due to the increased operating force.3.The operation wire came out from the caulking part due to the load exceeding the resistance.4.Clip could not be detached from the applicator.The event can be detected/prevented by following the instructions for use which state: ·"do not apply excessive bending, pulling or pressure to this product.It may lead to equipment damage or functional deterioration.·do not round the insertion tube smaller than 20 cm in diameter.The insertion tube may be damaged.·do not use excessive force to operate each part.It may lead to damage of rotating clip device and clip." olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was obtained regarding the event: - the reportable malfunction occurred during a diagnostic colonoscopy, hemostasis after therapeutic polypectomy.The procedure was successfully completed with a similar device.Since the clip could not be placed, the mucosa was not grasped.

• Brand Name: SINGLE USE RELOADABLE CLIP APPLICATOR
• Common Device Name: CLIP APPLICATOR
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18166438
• Report Number: 9614641-2023-01729
• Device Sequence Number: 20468344
• Product Code: PKL
• UDI-Device Identifier: 04953170421341
• UDI-Public: 04953170421341
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K183590
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: HX-810UR
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 12/19/2023
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown