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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FOOT SWITCH FOR UES-40 ELECTRO SURGICAL UNIT

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OLYMPUS MEDICAL SYSTEMS CORP. FOOT SWITCH FOR UES-40 ELECTRO SURGICAL UNIT Back to Search Results
Model Number MAJ-1258
Device Problem No Device Output (1435)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2016
Event Type  Malfunction  
Manufacturer Narrative

The subject foot switch maj-1258 was returned to olympus for evaluation. Olympus confirmed the subject device, and found there was abnormality of the subject device. There was no considerable damage on the outside of the subject device. A foot switch maker is going to investigate the subject foot switch. There were no further details provided at this time. If significant additional information is received, this report will be supplemented.

 
Event Description

During the panhysterectomy with the subject foot switch maj-1258 and ues-40, the user facility pressed the cut pedal of subject foot switch to activate the high frequency output, however the high frequency output was not activated. The user facility cycled the power of the subject ues-40 and the user facility pressed the cut pedal of subject foot switch to activate the high frequency output, however the high frequency output was not activated. The user facility pressed the coagulation pedal of subject foot switch to activate the high frequency output, the subject ues-40 normally activated the high frequency output. The user facility replaced the subject ues-40 with the surgical tissue management system (esg-400) and completed the procedure. There was no report of the patient injury other than replacing the device.

 
Manufacturer Narrative

This is a supplemental report for mfr report #8010047-2016-01609 to provide the device evaluation results. The foot switch maker evaluated the subject foot switch and found that it had no abnormality. The cut pedal and the coagulation pedal of the subject foot switch operated correctly. The subject foot switch was returned to olympus. Olympus evaluated the foot switch again and found that it had no abnormality and operated correctly. There were no further details provided at this time. If significant additional information is received, this report will be supplemented.

 
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Brand NameFOOT SWITCH FOR UES-40
Type of DeviceELECTRO SURGICAL UNIT
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951
ishikawa-cho
hachioji-shi, tokyo 192-8 507
JA 192-8507
Manufacturer Contact
susumu nishina
2951
ishikawa-cho
hachioji-shi, tokyo 192-8-507
JA   192-8507
42 6425177
MDR Report Key6204294
MDR Text Key63263979
Report Number8010047-2016-01609
Device Sequence Number1
Product Code KNS
Combination Product (Y/N)N
Reporter Country CodeCH
PMA/PMN NumberK030194
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,USER FACI
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/26/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMAJ-1258
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/13/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2017
Was Device Evaluated By Manufacturer? Yes
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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