MAUDE Adverse Event Report: MIZUHO CORPORATION 3503 EZ SLIDE; TABLE

Model Number	3503 EZ SLIDE
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Lack of Effect (4065)
Health Effect - Clinical Codes	Burn(s) (1757); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was a fire in their operating room after they heard popping and sparking sounds coming from the power outlet on the operating table in the hospital.The hospital suspects that the cause could have been liquid getting into the outlet.The failure occurred outside of the surgery.
Event or Problem Description
Here was a fire in their operating room after they heard popping and sparking sounds coming from the power outlet on the operating table in the hospital.The hospital suspects that the cause could have been liquid getting into the outlet.The failure occurred outside of the surgery.The distributor confirmed that the customer had used a beach chair to attach to the operating table.The beach chair was wet at the time, which may have allowed liquid to enter the electrical connectors of the operating table.In addition, the facility used an unauthorized power cord.The manufacturer discussed possible causes for the incident.The most likely scenario is that the entry of liquid, dust, and other contaminants into the electrical connectors of the operating table caused a short circuit.This, in turn, resulted in excessive current flow leading to ignition.The use of an unauthorized power cord could also have caused the short circuit.However, the exact cause of the incident remains undetermined as we have not been able to examine the actual product.The owner's manual states that caution should be taken when cleaning the table to prevent excessive fluid entry into electrical connectors, and that only authorized power cord should be used.
Additional Manufacturer Narrative
Manufacturer report number ; 1000159388202300001.

• Brand Name: 3503 EZ SLIDE
• Common Device Name: TABLE
• Manufacturer (Section D): MIZUHO CORPORATION; 3-30-13 hongo; bunkyo-ku; tokyo, tokyo 113-0 033; JA 113-0033
• Manufacturer (Section G): MIZUHO CORPORATION; JA
• Manufacturer Contact: 3-30-13 hongo, bunkyo-ku,; tokyo; tokyo, tokyo 113-0-033
• MDR Report Key: 17148961
• Report Number: 1000159388-2023-00001
• Device Sequence Number: 5589899
• Product Code: GDC
• UDI-Device Identifier: 10841736112165
• UDI-Public: (01)10841736112165(11)220531
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: D204524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 3503 EZ SLIDE
• Device Lot Number: 3503-SUT-20225-0878
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (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