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

Model Number UM-S20-17S

Device Problems No Display/Image (1183); Fluid/Blood Leak (1250)

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

Event Date 11/19/2023

Event Type  malfunction  

Manufacturer Narrative

Section e1: establishment name: (b)(6) hospital.The device was returned for evaluation and the customers allegation was not confirmed.It was noted that there were no issues with the device.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely that the following led to the malfunction: it was presumed that there was a hole in the tip sheath, and the blood invaded into the sheath from the hole, leading to the blood penetrating into the tip.It was presumed that the ultrasonic image was not rendered normally (missing image) because there was a hole in the tip sheath, the ultrasonic medium leaked out and decreased, and ultrasonic waves could not be transmitted normally.A definitive root cause cannot be identified.This issue is addressed in the instructions for use (ifu): not applicable as the failures were not due to user-misuse.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported to olympus, that the ultrasonic probe had a patients blood in it from previous use that had seeped inside of the tip.When the device was checked after cleaning, most of the blood had fallen out.It was noted that the image was missing after the device was connected.There was no patient harm or user injury reported.

• 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: 18320766
• MDR Text Key: 330943790
• Report Number: 3002808148-2023-14223
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K982323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2023

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-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2023
• 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