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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  
Event Description
The service center was informed by the biomedical technician at the user facility that the "sheathing is coming off" the ultrasonic probe during an unspecified event. The biomed technician reported it was "unknown" if there was any patient injury or patient involvement.
 
Manufacturer Narrative
As part of the investigation, olympus followed up with the user facility to obtain additional information regarding the reported event but with no results. The referenced device was returned to the service center for evaluation. The reported issue was confirmed as the protective sheathing was found torn and peeling off from probe. The device could not be tested in the received condition. The device is non-serviceable and was returned to the user facility unrepaired. The original equipment manufacturer performed the device history records for the concerned device; no abnormalities were found. The investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode. The concerned device was not returned to the oem for evaluation, therefore the exact cause of the report malfunctions could not be conclusively determined. However, based on the physical evaluation, the potential cause of the reported issue is due to external force. As stated on the ifu (instruction for use) and as a preventive measure, the ifu warns, "do not hit, stretch, twist, drop, or bend excessively the distal end, insertion section, or connector section of the ultrasonic probe. Otherwise, the equipment may be damaged, causing an injury in the body cavity, burns, bleeding, perforation, or detachment of parts. " the oem will continue to monitor complaints for this device.
 
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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
MDR Report Key12411385
MDR Text Key280933216
Report Number8010047-2021-11109
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K982323
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 09/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/01/2021
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 Manufacturer03/09/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Is This a Reprocessed and Reused Single-Use Device? No

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