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U.S. Department of Health and Human Services

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

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SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE Back to Search Results
Model Number UM-S20-17S
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/15/2023
Event Type  malfunction  
Event Description
It was reported to olympus, that the ultrasonic probe had air bubbles at the tip of the device and partially blurry image.Inspection and testing of the returned device found that there was a hole in the sheath at the tip and there was leakage of the ultrasonic medium.There were no reports harm associated with the event.This mdr is being submitted to capture the reportable malfunction found during the device evaluation.
 
Manufacturer Narrative
The device was returned for evaluation and the customers allegation was confirmed.It was noted that blurred image occurred due to air bubbles at the tip due to occurence of the hole in the sheath.There is a hole in the apical sheath.Additionally, there was leakage of the ultrasonic medium.A review of the device history record found no deviations that could have caused or contributed to the reported issue.A definitive root cause cannot be identified.However, based on the results of the investigation, it is likely that the following led to the malfunction: image is unclear: it is presumed that the ultrasonic image resulted in an event in which the ultrasonic image could not be rendered normally because the ultrasonic medium inside the sheath leaked out due to the occurrence of a hole in the sheath at the tip, and thus the ultrasonic wave could not be transmitted normally.For air bubbles: since a hole is made in the sheath at the tip, air enters into the sheath, so even if air bubbles are removed normally, it is presumed that air bubbles are generated again.About a hole in the sheath at the tip and leakage of ultrasonic media: a perforation has occurred in the apical sheath, indicating that an impact has been applied to the apical sheath.At that time, it is assumed that the ultrasonic medium inside the sheath leaked out because the sheath at the tip was damaged, leading to a hole.This issue is addressed in the instructions for use (ifu): after checking the instructions and product labeling, there were no abnormalities that could lead to the phenomenon.Olympus will continue to monitor the field performance of this device.
 
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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 Key17372470
MDR Text Key320152233
Report Number3002808148-2023-07373
Device Sequence Number1
Product Code ITX
UDI-Device Identifier04953170368479
UDI-Public04953170368479
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K982323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/21/2023
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 NumberUM-S20-17S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2023
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/22/2023
Initial Date FDA Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/25/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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