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

Model Number	UES-40
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Olympus medical systems corp.(omsc) was informed by the customer that during the preparation for use, there was no output coming through both monopolar ports and there was abnormal sound through fan.Error 02 was also coming.There was no report of patient injury associated with the event.The event date was unknown.
Additional Manufacturer Narrative
The subject device was returned to local service department of olympus.Local service department checked the subject device and found that the oscillator fan was making abnormal sound.The exact cause of the reported event could not be conclusively determined at this time.If additional information is received, this report will be supplemented.
Additional Manufacturer Narrative
This is a supplemental report to correct aware date.The correct aware date of the issue of abnormal noise was august 24, 2021, not october 29, 2021 as reported in initial mdr.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the device evaluation, the legal manufacturer's final investigation and corrections to g2 and h6.G2 - checked "other" to add the country india.H6 - corrected the component code.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device met all specifications at the time of shipment.It has been over 7 years since the subject device was manufactured.Based on the results of the investigation, the cause of the abnormal sound through the fan was likely from dust accumulated inside the device which occurred from the environment in which the device was operating.The specific root cause could not be determined at this time.Olympus will continue to monitor field performance for this device.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12867041
• Report Number: 8010047-2021-14988
• Device Sequence Number: 3607832
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030194
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2022

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: UES-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 05/31/2022
• Initial Report FDA Received Date: 11/24/2021
• Supplement Report FDA Received Date: 12/17/2021; 06/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown