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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-3R-3
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/11/2020
Event Type  malfunction  
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. The user forcibly insert, or withdraw the device into the bending section of the endoscope with the bending section bent and it caused the failure. During probe rotation, the user forcibly insert, or withdraw the device into the endoscope, and it caused the failure. The instruction manual provides preventive measures against the reported failure mode.
 
Event Description
The customer found fluid coming out of the distal tip of the device, which was at the storage area. This is a sign of device breakage. Other detailed information was not provided. There was no report of patient injury associated with the event.
 
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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 Key11061596
MDR Text Key223460599
Report Number8010047-2020-10836
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K001203
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM-3R-3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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