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

Model Number	UM-G20-29R
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation as noted in section b5, the subject device had dents at the tip of the insertion part, and ultrasonic probe damage.Based on the results of the investigation, the actual product had an indentation at the tip of the insertion part.The indentation suggests that an external force was applied to the tip of the insert.However, the information obtained from this complaint and the investigation results did not allow us to determine the cause of the indentation.A device history record-dhr review was conducted, and no issues were identified.The event can be detected/prevented by following the instructions for use which state: [section where ifu applicable for dents at the tip of the insertion part and ultrasonic probe damage] "¦observation of ultrasound images (warning): do not push or pull the ultrasonic probe with strong force or pull it into the bend of the endoscope while the ultrasonic 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 ultrasonic probe exhibited dents at the tip of the insertion part and probe damage.There was no patient involvement.
Additional Manufacturer Narrative
This supplemental is being submitted to inform the device returned date.
Event or Problem Description
It was observed that during the device evaluation, the ultrasonic probe exhibited dents at the tip of the insertion part and probe damage.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: 19580292
• Report Number: 3002808148-2024-34183
• Device Sequence Number: 17940941
• 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,Followup
• Report Date (Section B): 08/02/2024

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: Other
• Device Model Number: UM-G20-29R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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