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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT

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OLYMPUS MEDICAL SYSTEMS CORP. ELECTROSURGICAL UNIT Back to Search Results
Model Number UES-40
Device Problem Insufficient Information (3190)
Patient Problem Blood Loss (2597)
Event Date 08/25/2017
Event Type  Injury  
Manufacturer Narrative
The referenced ues-40 is not return to olympus medical systems corp. (omsc) for evaluation, therefore omsc cannot evaluate the ues-40 yet. Therefore the exact cause of the reported event could not be conclusively determined at this time. However, according to the literature, postoperative bleeding is known as common complication of tur-p procedure. Furthermore, it was aware that the facility reused the disposable electrode. The reported phenomenon is thought of as common complication of tur-p procedure with incorrect usage of the device. The ues-40 instruction manual states the notice for bleeding and appropriately handling of the device. There were no further details provided. If significant additional information is received, this report will be supplemented. This report is 3 of 5.
 
Event Description
A couple of days after the turis-p procedure, the bleeding were observed through the drainage catheter for five patients. The physician performed the irrigation of the bladder. The patients were prolonged the hospitalization.
 
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Brand NameELECTROSURGICAL UNIT
Type of DeviceELECTROSURGICAL UNIT
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
MDR Report Key6921405
MDR Text Key88922889
Report Number8010047-2017-10113
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
K030194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other Health Care Professional
Device Model NumberUES-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/09/2017
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

Patient Treatment Data
Date Received: 10/06/2017 Patient Sequence Number: 1
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