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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 Problems Crack (1135); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/13/2024
Event Type  malfunction  
Event Description
It was reported the subject device sheath was bent and the plastic was damaged.The probe functioned and did not give any error messages.The issue was found after the case was completed.There was no patient involvement.
 
Manufacturer Narrative
The device was returned and the evaluation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
 
Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned for evaluation and the customer's allegation was confirmed.In addition, the following reportable malfunctions were identified during the device evaluation: probe¿s cable section was cracked, resulting in internal oil leakage.Based on the results of the investigation, the most probable cause of the complaint is cause traced to component failure, which is expected or random component failure without any design or manufacturing issue.However, the definitive root cause of the reported issue could not be determined.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Olympus will continue to monitor the performance of this device.
 
Event Description
It was reported the subject device sheath was bent and the plastic was damaged.The probe functioned and did not give any error messages.The issue was found after the case was completed.There was no patient involvement.
 
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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 961-8 061
JA   961-8061
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key18896235
MDR Text Key337577022
Report Number3002808148-2024-31385
Device Sequence Number1
Product Code ITX
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 04/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2024
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? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2024
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/30/2021
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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