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	04/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The nurse at the user facility reported to olympus that during reprocessing after the procedure, the rotatable clip fixing device was washed by hand using ¿endofresh¿ and after applying ¿stin milk¿, the device was hung for drying and blood was found dripping from the coil sheath of the device.No death or injury and no impact to patient or other was reported as a result of the defect.It was reported the reprocessing of the device did not involve ultrasonic cleaning but was autoclave sterilized after washing by hand.This report was submitted to the report of capture the potential for insufficient cleaning.
Additional Manufacturer Narrative
No device was returned for evaluation as the device was discarded by the user facility.The lot number was unknown or not provided by the customer; therefore, a review of the device history records (dhr) for the affected device could not be performed.However, a review of the dhr was performed for about one year from the date of occurrence, and no abnormalities were found in the inspection items related to the event.The root cause of the customer¿s reported event could not conclusively be determined.However, the instruction manual for this product contained the following description.Thorough cleaning prior to sterilization removes microorganisms and organic material that may interfere with sterilization effectiveness.Sufficient sterilization effect cannot be obtained if cleaning is neglected.All maintenance work described in this instruction manual should be completed on the same day that the rotary clip device is used.If you don't finish everything on the same day, it will be difficult to remove the dirt, and the bacteria attached to the rotating clip device will multiply, increasing the possibility of infection.After use, do not leave the product with dirt on it, and wash it immediately.Also, when cleaning, use a low-foaming, neutral cleaning solution for medical equipment.If you leave the product with dirt on it after use, or if you use an unspecified cleaning solution, the metal parts such as the hook and coil sheath may corrode and fall off during use.Olympus will continue to monitor complaints for this device.In general, the end-user is required to inspect the device for defects, check the function of all devices and have alternate equipment prior to use.

• 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 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16833461
• Report Number: 9614641-2023-00583
• Device Sequence Number: 7180522
• Product Code: MND
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/28/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 04/01/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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