MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL BASE; OPERATING TABLE

Model Number	5803
Medical Device Problem Codes	Use of Device Problem (1670); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
When the table was told to tilt, it tilted in the opposite direction, full tilt,.
Additional Manufacturer Narrative
Per the information obtained from investigation and device evaluation, it was found that 95ftlb was very loose and hence the table easily moved when rotation safety switch was turned off and 180 degree lock lever indicator was illuminated.The on/off switch was missing splash cover, power on indicator had damaged cover, and steer caster had been replaced with a brake caster, which was very loose.The investigation also found that this table was not properly maintained and/or serviced by the hospital as per manufacturer's recommended practices since its install in 2017.The findings are thus identified as maintenance issues that were improperly/not addressed by the user as recommended in the instructions for use.A repair in-service was completed by the manufacturer on (b)(6) 2024 that fixed the above-mentioned issues.The table was deemed safe for use by the service engineer.
Event or Problem Description
When the table was told to tilt, it tilted in the opposite direction, full tilt,.

• Brand Name: ADVANCED CONTROL BASE
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 19756950
• Report Number: 2921578-2024-00009
• Device Sequence Number: 9145417
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: (01)00842430106026
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2024

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: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 08/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2017
• 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