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	02/09/2024
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 that the wire coating of the rotatable clip fixing device had peeled and fell off.There were no reports of patient involvement.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was manufactured in september 2023.Based on the results of the investigation, the root cause of the event was unable to be identified.Device analysis confirmed that the metal pipe had been deformed and was interfering with the operating wire and the control wire.It was also noted that the coating had peeled off along the entire length of the control wire.The event can be detected/prevented by following the instructions for use which state: "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.Before use, check that there is no corrosion (tiny holes, dents, discoloration, etc.) on the hook or coil sheath, or that there is no abnormality in the feel of operation.Using this product with a corroded hook or coil sheath may lead to the hook or coil sheath falling off.During use, always check the endoscopic image to ensure that there are no abnormalities at the tip or that there is no abnormality in the feel of operation.If the hook or coil sheath falls off during use, retrieve it using grasping forceps, etc.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.Do not squeeze, wipe or rub the rotating clip device too hard, as this may damage the rotating clip device or reduce its functionality." 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: 19355285
• Report Number: 9614641-2024-01119
• Device Sequence Number: 7509601
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

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: 02/19/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/25/2024
• 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