MAUDE Adverse Event Report: MIZUHO CORPORATION MOT-VS500DKE; TABLE, OPERATING-ROOM, ELECTRICAL

Model Number	MOT-VS500DKE
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Bruise/Contusion (1754)
Date of Event	05/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the surgery, the locking handle of the leg section was not rotatable, so the leg section was loosen and fell down.Neither the surgeon, other staff nor the patient were injured.

• Brand Name: MOT-VS500DKE
• Common Device Name: TABLE, OPERATING-ROOM, ELECTRICAL
• Manufacturer (Section D): MIZUHO CORPORATION; 3-30-13 hongo; bunkyo-ku; tokyo, ; JA
• MDR Report Key: 20666153
• Report Number: 1000159388-2024-00001
• Device Sequence Number: 12887341
• Product Code: GDC
• UDI-Device Identifier: 04946329353839
• UDI-Public: 04946329353839
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/11/2024

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: MOT-VS500DKE
• Device Catalogue Number: 18-500-30
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown