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

Model Number	HX-810UR
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An olympus representative reported on behalf of the customer that the single use reloadable clip applicator had an issue.The customer successfully put the clip on the clip applicator, inserting the device through working channel, opening the clip, but at the point of closing the clip, the clip did not detach from clip applicator.The customer had to pull the clip applicator, with the clip on, away from the bleeding point and quickly resolve the bleeding with boston scientific resolution clip.The issue was observed during a therapeutic (hemostasis) procedure.The procedure was completed with a similar device.There were no reports of patient or user harm associated with this event.
Additional Manufacturer Narrative
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.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.Patient identifier related to (b)(6) - model number: hx-810ur, lot#: 2yk.
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, and the customer's complaint was confirmed (the clip did not come off the applicator, the internal wire became loose and fell out of the metal catheter).The connecting rod was not broken from the clip, but the control unit was deformed.Olympus found the operating wire had come loose from the crimped part.There were no signs of breakage at the tip of the operating wire.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 event (the clip did not come off the applicator) occurred because the operating wire came off from the caulking part due to 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.In addition, the deformation of the control unit was considered to be caused by a load exceeding the resistance of the operation part.The event can be prevented by following the instructions for use which state: ·"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.·do not pull the slider of this product until it hits the end, and do not operate the angle of the endoscope before clipping is completed.It may lead to perforation, major bleeding, mucous membrane damage, etc.·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.·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".·do not press the clip too much against the desired tissue.The intended performance may not be achieved, such as the clip being deformed and not closing completely.·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.

• 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: 17550541
• Report Number: 9614641-2023-01159
• Device Sequence Number: 6939571
• Product Code: PKL
• UDI-Device Identifier: 04953170390739
• UDI-Public: 04953170390739
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2023

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 Expiration Date: 10/31/2025
• Device Model Number: HX-810UR
• Device Lot Number: 2YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HX-610-090L LONG CLIP.
• Patient Sex: Unknown