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

Model Number	UM-3R-3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to an olympus service center for evaluation.Service confirmed that the ultrasonic medium was leaking.When the device was connected and operated according to the instruction manual, there were no other abnormalities observed.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported that when preparing the device for use during a diagnostic ultrasonography procedure, the subject device had a leakage of ultrasonic medium from the insertion tube.The issue was identified during the first use after delivery to the facility.There was no patient or user injury reported due to the event.
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.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, due to perforation at the distal end sheath caused by external force that was likely applied when an indentation occurred at the distal end sheath, probe ultrasonic medium liquid leakage seems to have occurred.A definitive root cause cannot be identified."ultrasonic probe um-2r/um-3r/um-4r 6 operation 6.4 withdrawing from the endoscope 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.When using a gastrointestinal scope with a forceps elevator or a rigid scope with a deflector, always lower the forceps elevator or the deflector before withdrawing the ultrasonic probe.Withdrawing the probe with the forceps elevator or the deflector raised may result in damage to the probe." olympus will continue to monitor the field performance of 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: 14018409
• Report Number: 8010047-2022-05764
• Device Sequence Number: 12296351
• Product Code: ITX
• UDI-Device Identifier: 04953170063213
• UDI-Public: 04953170063213
• 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,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2022

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-3R-3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2022
• 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: 03/07/2022
• Supplement Date Received by Manufacturer: 04/15/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 05/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown