MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ULTRASONIC GENERATOR

Model Number	USG-400
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device in this report has not yet been returned to olympus medical systems corp.(omsc) for evaluation.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available or if the device is returned at a later time, this report will be supplemented.
Event or Problem Description
The subject device was used during an uncertain procedure of esophagus.The sound of device activation gradually lessened and finally it was impossible to hear the sound.The procedure was completed with another usg-400.There was no patient harm reported.
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc performed the following evaluations.Device manufacturer date was identified and filled in the section.The manufacturing record was reviewed with no irregularities.Omsc tried to reproduce the reported event, but it wasn't reproduced.There was a scratched on the surface of the front panel of the device, and it might be caused to contact with hard object.Omsc considered the design of the device and the event, and omsc concluded that the scratch wasn't the cause of the reported event.Omsc couldn't reproduce the event and the exact cause of the reported event could not be conclusively determined.The instruction manual of the subject device already states; never use the ultrasonic generator on a patient when any irregularity is observed with the equipment.Otherwise, the system may not work properly and serious injury to the patient, surgical staff and/or surgeon may result.

• Brand Name: ULTRASONIC GENERATOR
• Common Device Name: ULTRASONIC GENERATOR
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• MDR Report Key: 5982302
• Report Number: 8010047-2016-01234
• Device Sequence Number: 18853332
• Product Code: GEI
• UDI-Device Identifier: 04953170306747
• UDI-Public: (01)04953170306747
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2016

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: USG-400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/02/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2016
• Supplement Report FDA Received Date: 12/15/2016
• Patient Sequence Number: 1