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

Model Number	HX-110QR
Medical Device Problem Code	Device Reprocessing Problem (1091)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was used by the facility for two months after the delivery of the device.So the number of cases, for which the device was used is unknown.The device was returned.And customer allegation was confirmed.A black foreign substance was found on the gauze.The appearance of the hook was checked and no bends or deformities was found.There were no problems with hook extrusion and retraction.It was found, that the coating (black part) of the operating wire was peeling off.The investigation is ongoing.A supplemental will be submitted on completion of investigation or if any additional information is received.
Event or Problem Description
The customer reported to olympus, when the user moved the operating handle of the rotatable clip fixing device.Black sand like foreign material came out of the coil sheath from the tip of the device.The issue was found during reprocessing.The device was washed again, but the same issue occurred again.After the foreign material was found, the device was not used.And there were no reports of any health damage or patient harm associated with the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was manufactured in september 2022.However, the specific date is unknown.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, the definitive root cause of the foreign material and peeled coating could not be determined.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿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: 16952890
• Report Number: 9614641-2023-00690
• Device Sequence Number: 7012881
• Product Code: PKL
• UDI-Device Identifier: 04953170200205
• UDI-Public: 04953170200205
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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 Model Number: HX-110QR
• Device Lot Number: 29K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS ULTRASONIC CLEANER.
• Patient Sex: Unknown