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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
Medical Device Problem Code Noise, Audible (3273)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 07/13/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The olympus local service department checked the subject device and found that the reported phenomenon could not duplicated.The subject device was returned to the user, but the subject device returned again to the olympus local service department for further inspection.A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from the user that during a procedure of fistula and trans-urethral resection in saline with subject device, abnormal noise was generated from the subject device.The user completed the procedure by using the subject device.Other detailed information was not provided.There was no report of patient injury associated with the event.
 
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Brand Name
ELECTROSURGICAL UNIT
Common Device Name
ELECTROSURGICAL UNIT
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key12279102
Report Number8010047-2021-09824
Device Sequence Number19753230
Product Code GEI
UDI-Device Identifier04953170287275
UDI-Public04953170287275
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K030194
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 08/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberUES-40
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/13/2021
Initial Report FDA Received Date08/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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