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

Model Number	HX-110QR
Medical Device Problem Code	Failure to Clean Adequately (4048)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
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 reported that the rotatable clip fixing device had problems caused by improper reprocessing (foreign matter).There were no reports of patient harm.
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: h3, h6, h10.Corrected fields: b5,d8, e1 (first name, telephone number removed and establishment name changed to olympus), e2 and e3, g2 (the user facility checkbox should be left blank, and the company representative checkbox should be marked).Correction is being made to previously submitted g3- date received by manufacturer, which was not late.The correct date was 05/27/2024.Based on the results of the investigation, the root cause could not be determined.However, it is likely that the liquid used for cleaning (cleaning fluid or lubricant) adhered to the surface and then dried up in the autoclave, leading to the stain on the sterilized pack.The event can be prevented by following the instructions for use which states: "rinsing: after ultrasonic cleaning, rinse the instrument thoroughly to remove residual detergent.Residual detergent solution could cause tissue irritation in the next patient.1.Rinse the instrument under clean running potable water.2.Confirm that no debris is left on the surfaces of the instrument.3.Wipe the exterior of the instrument with a clean, dry lint-free cloth.Lubrication: 1.Immerse the insertion portion in the lubricant for 2 ¿ 3 seconds.2.Remove the instrument from the lubricant.3.Move the slider back and forth two or three times to retract the hook into and extend it from coil sheath.4.Wipe the exterior of the instrument with a clean, dry lint-free cloth." olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed during the device inspection, that the rotatable clip fixing device exhibited a stain on the sterilization pack.There were no reports of patient involvement.

• 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: 19499585
• Report Number: 9614641-2024-01227
• Device Sequence Number: 18110445
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2024

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-110QR
• Device Lot Number: 9ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2024
• Supplement Date Received by Manufacturer: 06/24/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 07/11/2024
• 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