MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ROTATABLE CLIP FIXING DEVICE

Model Number	HX-110UR
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.The case is not due to design.The device was not returned to olympus for evaluation.Therefore, a definitive root cause could not be determined at this time.The contents of the instruction manual warns: -the rotating clip device is not sterilized before shipping.Please wash and sterilize according to the following procedure before the first use.If used without cleaning or sterility, it may lead to infection or tissue inflammation.-if the rotating clip device is not effectively cleaned and sterilized after use, it may lead to infection and tissue inflammation.Also, the rotating clip device generally comes into contact with the mucous membranes during use.Clean and properly sterilize after use to reduce the risk of infection -wash thoroughly before sterilization to remove microorganisms and organic substances that may interfere with the sterilization effect.If cleaning is neglected, sufficient sterility will not be obtained.The device was not returned to olympus for evaluation.
Event or Problem Description
The customer reported that the reusable rotating clip was used in a lower endoscopic procedure without sterilization after ultrasonic cleaning.There has been no report of patient injury due to the event.Additional details have been requested regarding the reported event.At this time, no additional information has been provided.
Event or Problem Description
The customer was contacted for additional information.The customer reported that the patient has not exhibited any signs or symptoms of an infection due to the event (reusable rotating clip was ultrasonically cleaned, but not sterilized, prior to use).No other information was provided.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received from the user facility.

• Brand Name: ROTATABLE CLIP FIXING DEVICE
• Common Device Name: ROTATABLE CLIP FIXING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13941949
• Report Number: 8010047-2022-05238
• Device Sequence Number: 6431677
• 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,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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-110UR
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 03/29/2022
• Supplement Report FDA Received Date: 07/25/2022
• 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