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

Model Number	HX-810UR
Medical Device Problem Code	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that the clip applicator could not release the clip.No adverse effects to patient reported.This report is related to linked patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection.The operation wire was detached from the main body of the rotary clip device.The operation wire was missing from the crimped part.When the tip of the control wire was checked, there was no trace of breakage.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, it is likely the reported 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 a definitive root cause could not be identified.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.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on customer-provided event information and corrected lot number information.
Event or Problem Description
The customer reported the issue was detected during a therapeutic endoscopic submucosal dissection.The procedure was completed with a similar device.The customer reported the procedure was not prolonged or delayed to a clinically relevant extent.

• 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: 18184865
• Report Number: 9614641-2023-01756
• Device Sequence Number: 20642412
• Product Code: PKL
• UDI-Device Identifier: 04953170390739
• UDI-Public: 04953170390739
• 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,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/13/2024

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: 2YK10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2023
• Supplement Date Received by Manufacturer: 01/10/2024; 02/12/2024
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 01/10/2024; 02/13/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose