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
Additional Manufacturer Narrative
To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow-up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
Event or Problem Description
The customer reported to olympus that the clip on the single use reloadable clip applicator could not be released, as the wires become loose during the clip set up.The customer also mentioned that the 2yk charger was affected.The issue was found during a therapeutic procedure.There were no reports of patient harm or impact associated with the reported event.This report is related to patient identifiers: (b)(6).
Additional 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 found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause of the event was unable to be identified.The event likely occurred due to the following: 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.The event can be detected/prevented by following the instructions for use which state: 1) "do not pull out the rotary clip device until it hits the slider of this product and clipping is not completed.It may lead to perforation, major bleeding, mucous membrane damage, etc." 2) "if the clip does not come off from the rotating clip device, do not forcibly pull out the sheath.It may lead to perforation, major bleeding, mucous membrane damage, etc." 3) "this product is intended to be used only when surgical operations are possible as an emergency measure.In the unlikely event that the clip does not come off the rotating clip device, see "chapter 4 emergency actions".Olympus will continue to monitor field performance for this device.

• 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: 18150751
• Report Number: 9614641-2023-01721
• Device Sequence Number: 6747385
• 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): 02/02/2024

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?: Device Returned to Manufacturer
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2022
• 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