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

Model Number	UM-G20-29R-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device was returned to olympus for evaluation.The customer¿s reported problem was not confirmed/duplicated no bubbles specifically were present, however, liquid was found leaking from the tip of the device which may have contributed to the customer event.No ultrasonic image is displayed.The investigation is ongoing; therefore, the root cause of the reported issue cannot be determined at this time.However, if additional information becomes available this medical device report will be supplemented accordingly.
Event or Problem Description
Olympus (oj) was informed that the user facility ¿inspected the operation of the ultrasonic probe, bubbles were found at the tip¿.The problem was found during inspection before use.The intended procedure was completed with another similar device.No death, injury or harm was reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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, a definitive root cause could not be determined.However, it is likely that since the sheath of the distal end was perforated, air bubbles entered from the perforated parts.It was surmised that this phenomenon occurred because ultrasonic medium leaked.The following is included in the instructions for use (ifu): "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 field performance for this device.

• 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: 14793618
• Report Number: 8010047-2022-10717
• Device Sequence Number: 4895559
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2022

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: UM-G20-29R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2022
• 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: 05/26/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 06/23/2022
• Supplement Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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
• Patient Sex: Unknown