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

Model Number UM-G20-29R

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

E1: full facility name: (b)(6) hospital.The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation also found leakage of ultrasound media and hole in the sheath at the tip.A definitive root cause cannot be identified.A device history review of the current product was conducted, and no problems were found.This issue is addressed in the instructions for use (ifu): the ultrasound device is used only for ultrasound examination.Please turn the freeze switch of the ultrasound observation device on (freeze state) except during ultrasound diagnosis.When driving the ultrasound probe, please return the endoscope curvature and forceps raising as much as possible.Driving the probe with a harsh probe shape may result in image distortion or damage to the ultrasound probe.Do not push or pull the ultrasonic probe with strong force or pull it into the endoscope's curvature while the ultrasonic probe is driven (freeze release state).Push and pull the ultrasonic probe slowly, especially when the endoscope is strongly bent or when forceps are 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's curvature and forceps erection as much as possible.If the probe is driven with a harsh probe shape, there is a possibility of image distortion or damage to the ultrasound probe.- the following description is found in the inspection of the product in the instruction manual ""instructions for use.Check that there is no significant breakage or leakage of the medium over the entire length of the probe by lightly pinching the insertion part of the probe with your finger.The most probable cause of the complaint is cause traced to component failure, the presence of a hole in the tip sheath indicates that some stress was applied to the tip sheath.The ultrasonic medium inside the sheath leaked from the hole and decreased, resulting in the inability of ultrasonic waves to be transmitted normally and the inability of ultrasonic images to be drawn normally.The tip sheath was subjected to an impact, resulting in a hole in the tip sheath, which is assumed to have caused the leakage of ultrasound media.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported, the subject device had an echo image that did not appear.The issue occurred during a diagnostic endoscopic retrograde cholangiopancreatography (ercp) procedure that was completed using the same set of equipment.There were no reports of patient injury or harm associated with this event.

• Brand Name: ULTRASONIC PROBE
• Type of Device: 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: 18794595
• MDR Text Key: 337512586
• Report Number: 3002808148-2024-31032
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368578
• UDI-Public: 04953170368578
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2024

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
• Device Operator: Health Professional
• Device Model Number: UM-G20-29R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1