• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC PROBE Back to Search Results
Model Number UM-G20-29R-3
Device Problems Break (1069); Erratic or Intermittent Display (1182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2020
Event Type  malfunction  
Manufacturer Narrative
The device was returned to omsc. Omsc investigated the device and confirmed the following: the reported phenomenon that a large part of the ultrasonic image was not displayed was not reproduced. The ultrasound image was displayed properly. There was a hole in the distal end of transparent sheath section, causing an ultrasonic propagation fluid leak. There were black spots on the ultrasonic transducer. Since there was a hole in the distal end of transparent sheath section, there is possibility that air bubbles have temporarily entered the ultrasonic transducer. Omsc concluded that the ultrasound image may have been abnormal because the ultrasound could not be transmitted normally due to the intrusion of air bubbles onto the ultrasonic transducer. The perforation of the distal end of transparent sheath section may have been caused by an external force applied to the distal end due to the following causes; with the ultrasonic probe driven, the ultrasonic probe was pushed and pulled vigorously from the endoscope. With the endoscope bent, the ultrasonic probe was pushed and pulled vigorously from the endoscope. There is possibility that an external force was applied to the distal end of transparent sheath section, which caused the ultrasonic transducer to be impacted and damaged, resulting in black spots on the ultrasonic transducer. However, omsc concluded that the ultrasonic transducer was not failed because the ultrasound image was displayed properly. Device history record (dhr) review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) was informed by the user that during the procedure, a large part of the ultrasonic image was not displayed, and only about 20% of the image was displayed. The user replaced the device to another device and completed the procedure. The device was used with an olympus flex videoscope tjf-260v. There was no report of patient injury associated with the event. Omsc inspected the device and found that the ultrasonic image was noisy and there was a scratch on the distal end of transparent sheath section.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11190896
MDR Text Key227944520
Report Number8010047-2021-01589
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 user facility
Reporter Occupation
Type of Report Initial
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM-G20-29R-3
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

-
-