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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE

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SHIRAKAWA OLYMPUS CO., LTD. ULTRASONIC PROBE Back to Search Results
Model Number UM-S20-17S
Device Problem Device Contamination with Body Fluid (2317)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2023
Event Type  malfunction  
Manufacturer Narrative
At this time olympus has not received this device back for testing and evaluation.Should the device be returned, an evaluation will be completed, and a follow up report will be submitted.
 
Event Description
The customer reported to olympus the ultrasonic probe that holds the catheter contained blood that could not be removed.The reported issue was discovered after an unknown therapeutic procedure during reprocessing (after high level disinfecting) of the scope.There was no patient/user harm or injury reported due to the event.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the root cause could not be conclusively determined as the device was not returned for evaluation.Multiple attempts were performed to obtain the device, but no response was received from the customer.Based on the available information, it is likely the sheath at the distal end of the probe had perforated due to the user's handling, and blood had invaded inside the sheath through the damaged part during the procedure.The event can be prevented by handling the device in accordance with the following instructions for use (ifu): "never push or pull the ultrasonic probe with excessive force or withdraw it into the bending section of the endoscope during probe rotation (real-time mode).Manipulate the ultrasonic probe slowly and carefully when the endoscope is sharply angled or the forceps elevator is raised.Forcefully pushing or pulling the ultrasonic probe may damage it." olympus will continue to monitor field performance for this device.
 
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Brand Name
ULTRASONIC PROBE
Type of Device
ULTRASONIC PROBE
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
Manufacturer (Section G)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura,
nishishirakawa-gun, fukushima
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key17375007
MDR Text Key320379727
Report Number3002808148-2023-07386
Device Sequence Number1
Product Code ITX
UDI-Device Identifier04953170368479
UDI-Public04953170368479
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 09/11/2023
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/28/2023
Initial Date FDA Received07/21/2023
Supplement Dates Manufacturer Received09/07/2023
Supplement Dates FDA Received09/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/03/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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