MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. ISOLATIONTRANSFORMER 100V

Model Number	MB-631
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Olympus medical systems corp.(omsc) investigated the device and found the following.There was a dissolution sign on the device.Omsc considered that high heat was generated from the melting part and gradually melted.The maximum power consumption of the device was exceeded the actual rated capacity of the mb-631.The label of the device describes as "rated capacity: 750va".However, omsc confirmed that the maximum power of power consumption devices exceeded at least 800va.Therefore, omsc concluded that this phenomenon attributed to using with exceeding the rated capacity of the actual product.If significant additional information is received, this report will be supplemented.
Event or Problem Description
The user used the otv-s7 (the video system center), clv-s40 (light source), a monitor (the model number was unknown), and this mb-631 (an isolation transformer).The user connected mb-631 from a wall outlet via an extension cord.No other device was connected to the extension cord.The user found that the plug of mb-631 was burnt.It is unknown if the power of these devices was turned on when the event occurred.It is unknown whether the device sparked or the fire went up.After this event, the device could be used without any problems.There were no reports of patient injuries related to this incident.The user facility did not provide other detailed information.

• Brand Name: ISOLATIONTRANSFORMER 100V
• Common Device Name: TRANSFORMER
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11751187
• Report Number: 8010047-2021-05648
• Device Sequence Number: 17003937
• Product Code: FET
• UDI-Device Identifier: 04953170026669
• UDI-Public: 04953170026669
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: MB-631
• Device Lot Number: 23946
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1