MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

Model Number	UM-G20-29R-3
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device was returned to olympus for evaluation.The customer¿s reported issue was as the device image cannot be drawn normally.Additionally, there is a hole in the tip of the sheath and there is a leak in the ultrasonic medium.The legal manufacturer performed a review of the device history records for the concerned device and no abnormalities were found.The investigation was completed by the legal manufacturer and determined that there is no manufacturing, material or processing related cause for this failure mode.However, the potential cause of the ultrasonic medium leak from the hole is due to external force which is the same as the pressure mark on the sheath of the distal end; therefore, the ultrasonic wave could not be transmitted properly and the ultrasonic image was not properly displayed.In general, the customer is required to check the function of all devices used prior to a procedure and a suitable replacement device must be provided during an application.As stated on the ifu (instructions for use manual) and as a preventative measure, the ifu states the following: chapter 3 preparation, inspection and operation, - when withdrawing the ultrasonic probe, always set the ultrasound system to the freeze mode.Withdrawing when the ultrasonic probe is rotating may result in damage the probe.Olympus will continue to monitor complaints for this device.
Event or Problem Description
Olympus was informed that ¿during pre-use inspection, it was discovered that the eus (endoscopic ultrasound) mage of the ultrasonic probe could not be drawn¿ the probe was replaced with another probe and the procedure was completed.No death, injury or harm was reported.

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• 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: 14502550
• Report Number: 8010047-2022-08905
• Device Sequence Number: 5151563
• Product Code: ITX
• UDI-Device Identifier: 04953170078668
• UDI-Public: 04953170078668
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001203
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2022

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: Other
• Device Model Number: UM-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 05/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2022
• 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: OLYMPUS MODEL : EU-ME2; OLYMPUS MODEL : MAJ-935
• Patient Sex: Unknown