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

Model Number	UES-40
Medical Device Problem Code	Failure to Deliver Energy (1211)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject ues-40 will not be returned to olympus.There were no further details provided.If significant additional information is received, this report will be supplemented.
Event or Problem Description
During the unspecified therapeutic procedure with the ues-40, the user felt the output of the ues-40 was not appropriate.After activating the ues-40 for unspecified periods, the user felt the output of the ues-40 became appropriate suddenly.The user replaced the subject ues-40 with an unspecified similar system.There was no report of the patient¿s injury regarding this event.The local service engineer reported the following inspection result of the subject ues-40.No malfunction of the subject ues-40 occurred and the phenomenon that the user mentioned could not be reproduced.All measured values of the inspection were within the range of specifications.
Additional Manufacturer Narrative
The subject ues-40 did not return to olympus medical systems corp.(omsc), omsc could not evaluate the subject ues-40.Omsc checked the device history record of the subject ues-40, there was no irregularity found.The local service engineer checked the subject ues-40 and reported that there was no abnormality.The exact cause of the reported event could not be conclusively determined, however there is the possibility of this event is attributed to followings.-the garbage and/or dirt adhered to the surface of the electrode of the high frequency accessory, or the part for the connection of the high frequency accessory and the a cord.The adhering material became a resistance ingredient, and the output of the subject ues-40 was unstable because the functional current of high frequency could not flow normally.The instruction manual states the proper handling method of the ues-40 and the corresponding method in case of abnormality.
Additional Manufacturer Narrative
This supplemental report is submitting to correct "device product code".

• Brand Name: ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8137017
• Report Number: 8010047-2018-02380
• Device Sequence Number: 2242216
• Product Code: GEI
• UDI-Device Identifier: 04953170287275
• UDI-Public: 04953170287275
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/29/2019

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: No Information
• Device Model Number: UES-40
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/12/2018
• Supplement Date Received by Manufacturer: 02/20/2019; 03/20/2019
• Initial Report FDA Received Date: 12/06/2018
• Supplement Report FDA Received Date: 03/14/2019; 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1