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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 Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/30/2021
Event Type  malfunction  
Event Description
Olympus medical systems corp.(omsc) was informed from the user that during the reprocessing, it was found that foreign objects (brown crystals) had adhered near the ultrasound transducer of the subject device.There was no report of patient injury associated with this event.
 
Manufacturer Narrative
The subject device was returned to omsc for evaluation.Omsc checked the subject device and confirmed that blood had invaded the inside of the distal end sheath and had adhered near the ultrasound transducer as reported.And it was found that there was a hole at the boundary between the distal end sheath (transparent sheath section) and the insertion tube (gray sheath section), and the ultrasonic propagation fluid medium had been leaked from the hole at the boundary portion.Also, it was found that there was a bulge at the boundary.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based upon the investigation result, omsc surmised that reported foreign objects adhering was caused by the invasion of blood from the hole into inside of the distal end sheath.And it was surmised that because the hole overlapped with the bulge, the distal end sheath receives an external force and the flexible shaft (internal blade) could not be rotate properly, the flexible shaft involved the insertion tube, consequently the insertion tube was twisted and broken.In addition, it was also surmised that the improper rotation of flexible shaft was attributed to the following.With the flexible shaft rotated, the subject device was pushed and pulled vigorously from the endoscope.With the endoscope angulated, the subject device was pushed and pulled vigorously from the endoscope.Both of the above.If additional information is received, this report will be supplemented.
 
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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 Key12694950
MDR Text Key282121387
Report Number8010047-2021-13624
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,health
Type of Report Initial
Report Date 10/26/2021
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 Manufacturer10/08/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/30/2021
Initial Date FDA Received10/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2014
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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