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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-S20-17S
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
The device was returned to the service center for evaluation. The customer¿s complaint was confirmed as the probe tip and its cover were found detached. Since the device is not serviced by olympus it was returned to the customer unrepaired. In addition, the legal manufacturer (lm) reviewed the content of this complaint for further investigation. As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation. Confirmed that there was no variation. The legal manufacturer reported that the root cause could not be determined. The lm reported that the most probable causes for the reported event are as follows: it was speculated that some external force was applied to the tip sheath, which resulted in the breakage of the tip sheath. Inspection results of the actual product indicate that the ultrasonic probe is damaged. From the above, it can be inferred that similar external forces were applied to the apical sheath. It is assumed that the external force applied when the stopper was used resulted in a complete rupture.
 
Event Description
The service center was informed that a component detached from the device, while attempting to place the stopper on. There was no patient involvement reported.
 
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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 Key11642239
MDR Text Key246481281
Report Number8010047-2021-04760
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 user facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUM-S20-17S
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/19/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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