MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE REPOSITIONABLE CLIP; SINGLE USE REPOSITIONAL CLIP

Model Number	HX-202UR
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The following patient identifiers are linked: (b)(6).This report has been submitted by the importer under this mdr report number 2429304-2025-00017.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during an unknown therapeutic procedure, 5 units of the subject device had never deployed.This resulted to the delay of the procedure for more than 30 minutes.The procedure was then completed with a competitor device.There were no reports of patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction, additional information from the customer and the results of the legal manufacturer¿s investigation.Updated fields: b5 and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, upon further follow-up, the customer confirmed that the patient did not suffer any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was not returned for evaluation; therefore, a definitive root cause could not be determined.The most probable cause was not established; the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
Additional information was received from the customer confirming that there was no patient harm from the procedural delay.

• Brand Name: SINGLE USE REPOSITIONABLE CLIP
• Common Device Name: SINGLE USE REPOSITIONAL CLIP
• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21106544
• Report Number: 9614641-2025-00021
• Device Sequence Number: 18338450
• Product Code: PKL
• UDI-Device Identifier: 04953170385940
• UDI-Public: 04953170385940
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K123601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HX-202UR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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