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

Model Number	UM-G20-29R
Medical Device Problem Codes	Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2: health professional ¿ n (no) and e3: occupation - non-healthcare professional.A definitive root cause could not be identified.Based on the results of the investigation, it is likely the following led to the malfunction: ultrasonic media leakage occurred in the actual product.Therefore, it was likely that "many bubbles" occurred due to ultrasonic media leakage.There was a tear at the tip of the insertion site and leakage of ultrasound media.The information obtained from this complaint and the investigation results did not result in the cause of the occurrence.A device history review (dhr) was completed, and no issues were identified.This issue is addressed in the instructions for use (ifu):** ¦3.5 how to use the product (warning) ¿ do not insert the ultrasound probe into the endoscope without a clear view of the endoscope.This may result in damage to the tissue in the body cavity and damage to the product.[section where ifu applicable for phenomenon 2] ¦observation of ultrasound images (warning) ¿ do not push or pull the ultrasonic probe with strong force or pull it into the endoscope's curved section while the probe is driven (unfrozen state).Push and pull the ultrasonic probe slowly, especially when the endoscope is strongly bent or forceps is being raised.Strong force or sudden movements may cause image distortion or damage to the ultrasound probe.¿ when driving the ultrasound probe, return the endoscope curvature and forceps raising as much as possible.Driving with a harsh probe geometry may lead to image distortion or damage to the ultrasound probe.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was observed that during the device evaluation, the subject ultrasonic probe exhibited a tear at the tip of the insert, ultrasound media leakage.There was no patient involvement.

• 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: 19386533
• Report Number: 3002808148-2024-33335
• Device Sequence Number: 12537969
• Product Code: ITX
• UDI-Device Identifier: 04953170368578
• UDI-Public: 04953170368578
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• 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