MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. ELECTROSURGICAL UNIT

Model Number	UES-40
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to an olympus service center for evaluation.Upon inspection and testing of the returned device, the reported issue (offensive odor) was confirmed and found to be caused by a connector failure.Service confirmed that part of the front panel was damaged (burnt) where the saline tool is inserted (connector failure).There was no visible damage to the inner parts of the device.There were no functional problems identified.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available, this report will be supplemented accordingly.
Event or Problem Description
The customer reported that during an unspecified therapeutic procedure, coagulation began to smell.The subject device was disconnected, and then it stopped working.It was observed there were burnt stains on the device cover.The intended procedure was completed using another device.There was no patient or user injury reported due to the event.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on the results of the investigation, the root cause of the customers reported event (saline connector burned and smelled) was unable to be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: ELECTROSURGICAL UNIT
• Common Device Name: ELECTROSURGICAL UNIT
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer Contact: masaharu hirose ; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8-061 ; JA 961-8061 ; 426422891
• MDR Report Key: 15084983
• Report Number: 3002808148-2022-00213
• Device Sequence Number: 14742845
• Product Code: GEI
• UDI-Device Identifier: 04953170165429
• UDI-Public: 04953170165429
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2022

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: 07/01/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 07/22/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2008
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown