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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 Problems Use of Device Problem (1670); Contamination /Decontamination Problem (2895)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/06/2017
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has been used continuously at the user facility. The exact cause of the reported event could not be conclusively determined however, it might be a simple human error as the user facility reported.
 
Event Description
Olympus was informed that a possibly contaminated gastroendoscope was used for a patient. Before use, the gastroendoscope was reportedly placed with the subject device which was not reprocessed with an automated endoscope reprocessor (aer). It was reported that the subject device was not reprocessed since the facility staff forgot to press the start button and took out the subject device from the aer without noticing of the uncompleted reprocess. It was also reported that the user facility will recall the patient for blood test and follow up the patient for three months. There was no report of infection at present.
 
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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
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key6559575
MDR Text Key75102306
Report Number8010047-2017-00569
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
PK944610
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/11/2017
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? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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