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

Model Number	MAJ-1258
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.

• Brand Name: FOOT SWITCH FOR UES-40
• Common Device Name: ELECTRO SURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• MDR Report Key: 6204294
• Report Number: 8010047-2016-01609
• Device Sequence Number: 426444
• Product Code: KNS
• UDI-Device Identifier: 04953170165481
• UDI-Public: 04953170165481
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2017

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 Number: MAJ-1258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/26/2016
• Supplement Report FDA Received Date: 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1