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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 Reprocessing Problem (1091)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2023
Event Type  malfunction  
Manufacturer Narrative
The device was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
The customer reported to olympus that the ultrasonic probe was coiled less than 20cm and stored in a case instead of a well-ventilated cabinet.There were no reports of patient or user harm.
 
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 of the event was unable to be identified.The device was not returned to olympus; however, contents of the report from the customer deviates from the contents of the instruction manual.Therefore, it is likely that the phenomenon occurred due to handling of the user.The event can be detected/prevented by following the instructions for use which state: "warnng: do not store the sterile packages containing the instruments in places where they could become damaged, wet, or improperly sealed.Otherwise, the sterility of the instruments may be compromised and pose an infection-control risk or cause tissue irritation.Do not store the ultrasonic probe in the shipping box.Use the box only for shipping the instrument.Routine storage in a humid, nonventilated environment, such as the shipping box, may present an infection-control risk.Caution: the storage cabinet must be clean, dry, well ventilated, and maintained at ambient temperature.Storing the ultrasonic probe in direct sunlight, at high temperatures, in high humidity, or exposed to x-rays may damage the components or present an infection-control risk.Do not coil the ultrasonic probe¿s insertion tube with a diameter of less than 20 cm.Instrument damage such as image flow and impeded or irregular rotation can result.Do not store the ultrasonic probe with the distal end pointing upward.Air bubbles inside the insertion tube will gather at the distal end and result in reduced performance.".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 Key18324237
MDR Text Key330944138
Report Number3002808148-2023-14243
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
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/26/2024
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 11/29/2023
Initial Date FDA Received12/14/2023
Supplement Dates Manufacturer Received03/21/2024
Supplement Dates FDA Received03/26/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/27/2023
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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