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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE
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OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE Back to Search Results
Model Number UM-S20-17S
Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc will start evaluating the device.There were no further details provided.If significant additional information is received, this report will be supplemented.
 
Event Description
Olympus medical systems corp.(omsc) was informed that in unspecified timing ultrasonic propagation fluid coming out of the distal tip of the device.Omsc confirmed the device.Omsc found that the distal tip of the device was broken and there was blood in the distal end of the insertion tube of the device.There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The device was returned to olympus medical systems corp.(omsc) for evaluation.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.Omsc confirmed the device, and could duplicate the user¿s report.The exact cause was unknown; however, omsc assumed a potential cause as follows.Because the user forcibly insert or withdraw the device into the bending section of the endoscope with the bending section bent, the distal tip of the device was broken and ultrasonic propagation fluid coming out of the distal tip of the device.Because during probe rotation, the user forcibly insert or withdraw the device into the endoscope, the distal tip of the device was broken and ultrasonic propagation fluid coming out of the distal tip of the device.The instruction manual provides preventive measures against the reported failure mode.
 
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Brand Name
ULTRASONIC PROBE
Type of Device
ULTRASONIC PROBE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key11283737
MDR Text Key234920424
Report Number8010047-2021-02250
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K982323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberUM-S20-17S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received01/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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