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

Model Number UM-G20-29R

Device Problems Break (1069); No Display/Image (1183)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The device evaluation found indentation at the tip of the insertion and damage to the ultrasonic probe.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu): 3.5 how to use this product (warning) ¿ do not insert the ultrasound probe into the endoscope without a clear view of the endoscope.Doing so may result in damage to tissues in the body cavity and damage to the product.¦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." olympus will continue to monitor the field performance of this device.

Event Description

It was reported that the subject device had image display issue.The issue occurred during preparation for use.The procedure was completed using similar device.There were no reports of patient harm.

• 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: 19149116
• MDR Text Key: 340952369
• Report Number: 3002808148-2024-32352
• Device Sequence Number: 1
• Product Code: ITX
• 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: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2024

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?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2023
• 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