MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. ROTATABLE CLIP FIXING DEVICE

Model Number	HX-110UR
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was observed during the device inspection, the rotatable clip fixing device operating wire was peeled and dislodged.There were no reports of patient involvement.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.New information added to the following fields: d8, h3, h6.Based on the results of the investigation and the state of the subject device, it is presumed that the peeling of the coating on the operation wire was caused by factors such as the coating part being rubbed against a hard object during use or reprocessing.However, the exact cause could not be identified.Olympus will continue to monitor the field performance for this device.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• 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: 20268296
• Report Number: 9614641-2024-01868
• Device Sequence Number: 19700370
• Product Code: PKL
• UDI-Device Identifier: 04953170200229
• UDI-Public: 04953170200229
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K013066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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-110UR
• Device Lot Number: 37K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown
• Patient Ethnicity: Non Hispanic