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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); Mechanical Jam (2983)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
Event Description
Olympus medical systems corp. (omsc) was informed from the user that it was found that the subject device was stuck in the guide sheath and the subject device could not be pulled out. The issue occurred when the subject device was removed from the guide sheath during the bronchoscopy. There was no report of patient injury associated with the event.
 
Manufacturer Narrative
The subject device was returned to olympus (b)(4). (b)(4) checked the subject device and removed both the subject device and the guide sheath at the same time and they passed through the endoscope with no difficulties. Then the subject device was returned to omsc for investigation with stuck in the guide sheath. Omsc checked the subject device and found following; - the subject device had a cut inside the guide sheath - the x-ray tip of the guide sheath was deformed and became oval shape, also the tube of the guide sheath was kinked. Omsc reviewed the device history record (dhr) of the subject device and confirmed no irregularity. Based upon the investigation, omsc surmised that the reported phenomenon was attributed to the stress was applied to the x-ray opaque tip due to the angle of the endoscope was strict when the endoscope was inserted. The phenomenon was caused by crashed radiopaque tip being deformed and stuck inside the guide sheath. Crashed radiopaque may have been attributed to a load applied to it when angulation too much during insertion of the endoscope. Olympus stated the appropriate handling of um-s20-17s and the counter measures against abnormalities in the instruction manual of um-s20-17s.
 
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Brand NameULTRASONIC PROBE
Type of DeviceULTRASONIC PROBE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA 192-8507
MDR Report Key12605498
MDR Text Key281324639
Report Number8010047-2021-12986
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,foreig
Type of Report Initial
Report Date 10/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM-S20-17S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/23/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No

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