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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 Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device in this report has not been returned to olympus medical systems corp. (omsc) for evaluation. The exact cause of the reported event could not be conclusively determined at this time. If additional information becomes available, this report will be supplemented.
 
Event Description
At the end of the bronchoscopy, the user found that a small piece of the distal end of the ultrasound probe fell off in the patient's body. The user removed the small piece from the patient body. The user took an x-ray analysis for the patient and confirmed that the piece was not left in the patient's body. There was no extension of the procedure relevant clinically. There were no reports of patient injuries related to this incident. The user facility did not provide other detailed information.
 
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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
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key12038313
MDR Text Key257458635
Report Number8010047-2021-07811
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K982323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/22/2021
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 Manufacturer06/17/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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