MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

Model Number	UM-DG20-31R
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection and testing, there was leakage of the ultrasonic medium from the insertion tube and blood had infiltrated the inside of the tip sheath.The reported issue (distorted image) was also confirmed during testing.A review of the device history record found no deviations that could have caused or contributed to the reported issues.The device shipped according to specifications.Based on the results of the legal manufacturer's investigation, it is likely that some external force was applied to the device leading to the perforation of the tip sheath, and leakage of ultrasonic medium from the broken part, which led to invasion of blood.The hole in the tip sheath also likely led to the image being distorted due to the decrease of ultrasonic medium and penetration of bubbles.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "do not push and pull the ultrasonic probe for three-dimensional scanning with strong force or pull it into the curved part of the endoscope while driving the ultrasonic probe for three-dimensional scanning (freeze release state).Pay special attention to pushing the 3-dimensional scanning ultrasound probe when the endoscope is strongly curved or when the forceps table is raised.Push and pull with strong force or sudden action may lead to image distortion or damage to the ultrasonic probe for three-dimensional scanning." olympus will continue to monitor field performance for this device.In addition, there was a twist in the sheath on the insertion part.Per the legal manufacturer, this device defect has no potential to cause or contribute to death or serious injury if the malfunction were to recur.
Event or Problem Description
The customer reported that, during preparation for use, the ultrasound echo image from the subject device was distorted.The planned procedure was completed using another similar device.There was no effect on the patient due to the event.The subject device was sent to olympus for evaluation.During inspection and testing, there was leakage of the ultrasonic medium from the insertion tube and blood had infiltrated the inside of the tip sheath.This report is being submitted for the malfunction found during evaluation (leakage of ultrasonic medium and infiltration of blood).

• Brand Name: ULTRASONIC PROBE
• Common Device Name: ULTRASONIC PROBE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 15780659
• Report Number: 3002808148-2022-04065
• Device Sequence Number: 4924469
• Product Code: FET
• UDI-Device Identifier: 04953170368462
• UDI-Public: 04953170368462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011886
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/11/2022

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-DG20-31R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• 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: 08/24/2022
• Initial Report FDA Received Date: 11/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2022
• 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