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

Model Number	UM-3R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, the leakage of the ultrasound medium (oil) from the insertion tube was found to be due to breakage of the insertion tube.The investigation is ongoing; therefore, a definitive root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The user facility reported that when preparing the subject device for use, the ultrasound image was abnormal.There was no report of patient/user harm or injury due to the event.The device was sent to an olympus service center for evaluation.Device inspection and testing confirmed the reported image issue.In addition, service observed ultrasonic medium (oil) leaking from the insertion tube.This report is being submitted for the reportable malfunction of the ultrasonic medium leakage.
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 less than 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that this phenomenon occurred due to the following: (1) the ultrasound media may have leaked from a hole on the distal end sheath but the cause of the hole could not be identified.(2) some external force was applied and made a hole at the sheath of distal end, broke the ultrasound probe or broke the cable.Unable to determine the cause of the damage from the photos.A definitive root cause cannot be identified.The instructions for use (ifu) instruction manual state: - ifu warns against this event as follows: ¿when using the ultrasonic probe during bronchoscopy, never use sterile, de-aerated water immersion method and balloon method.This could result in patient injury.¿ freeze the image whenever you are not actively viewing the ¿live¿ ultrasound image.When the equipment is in the freeze mode, no ultrasonic energy is emitted into the patient.¿ never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it.¿ do not attempt probe rotation while the ultrasonic probe is advanced abruptly.This could result in image flow and impeded or cause irregular rotation.¿ 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: 13763038
• Report Number: 8010047-2022-04394
• Device Sequence Number: 5974250
• Product Code: ITX
• UDI-Device Identifier: 04953170368561
• UDI-Public: 04953170368561
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2022
• Supplement Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 03/14/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown