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

Model Number UM-S20-17S

Device Problem No Display/Image (1183)

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

Event Date 01/26/2024

Event Type  malfunction  

Event Description

It was reported, hen using the probe for the first time after delivery, the image did not display properly.The issue occurred during inspection, prior to an unspecified procedure.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer¿s allegation was confirmed.The device evaluation found air bubbles had gathered at the tip during storage were not present in the sheath.Based on the results of evaluation, it is assumed that air bubbles that had gathered at the tip during storage could not be removed normally during inspection, and when the bubbles overlapped on the ultrasonic probe, ultrasonic waves could not be transmitted normally, resulting in the occurrence of the image not displaying properly.The product was judged to meet the product specifications because it became normal when the air bubbles were removed.The product in question is not a product subject to repair.A device history review was conducted, and no problems were found.This issue is addressed in the instructions for use (ifu): the following description is included in the inspection of the product in the instruction manual "preparation and inspection": the ultrasound probe is designed for use with ultrasound medium.The ultrasonic probe is sealed with ultrasonic medium (liquid).Depending on storage conditions and other factors, there may be air bubbles around the ultrasonic probe or no medium at the tip.Always inspect the ultrasonic probe for air bubbles as described here before using it.If there is no medium or bubbles around the ultrasonic probe, remove the bubbles according to the instructions in "3.3 removal of bubbles".Good ultrasound images cannot be obtained if there are air bubbles on the ultrasound probe.Olympus will continue to monitor the field performance of this device.

Event Description

It was reported, when using the probe for the first time after delivery, the image did not display properly.The issue occurred during inspection, prior to an unspecified procedure.The procedure was completed using a similar device.There were no reports of patient harm.

Manufacturer Narrative

This report is being submitted for a correction regarding reportability.Initially it was reported, the malfunction to be reportable.Upon further investigation, the subject device should be coded and reported as a non-reportable malfunction instead of a reportable malfunction.

• 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 01581-4003 ; 5082077661
• MDR Report Key: 18776620
• MDR Text Key: 337080969
• Report Number: 3002808148-2024-30987
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 04953170368479
• UDI-Public: 04953170368479
• 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: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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-S20-17S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/01/2024
• Supplement Dates FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2023
• 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