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	03/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was observed during the device inspection, that the rotatable clip fixing device exhibited wire coating peeled off and fell off.There were no reports of patient involvement.
Additional Manufacturer Narrative
The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.New information added to the following fields: h3 and h6.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, a definitive root cause could not be determined.However, it is likely that the operating wire coating of applicator peeled off occurred due to oxidation (rust) of the operation wire.The event can be detected and prevented by handling the device in accordance with the following instructions for use: before use, check that the hook and coil sheath are not corroded (microscopic holes, dents, discoloration, etc.) and that there is no abnormality in the operational feel.Using this product with corroded hook or coil sheath may cause the hook or coil sheath to fall off.During use, always check the endoscopic image to confirm that there is no abnormality in the tip and that there is no abnormality in the operability.In the unlikely event that the hook or coil sheath falls off during use, please retrieve it with grasping forceps.Do not squeeze, wipe, or rub the rotating clip device.It may lead to damage or deterioration of the function of the rotating clip device.Olympus will continue to monitor 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: 19140858
• Report Number: 9614641-2024-00938
• Device Sequence Number: 7406125
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: Other
• Device Model Number: HX-110UR
• Device Lot Number: 39K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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