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

Model Number	7803
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient fell during the transfer from the operating table back to the hospital bed.The frame was suspected to be unlocked which caused the patient to fall and hit the floor.
Additional Manufacturer Narrative
Per the information obtained from the investigation, it was found out that there was no reported patient fall and no problems with the device.The hospital personnel failed to lock the rotation lever which the caused a swinging motion of the table prior to transferring the patient from the hospital bed to the table.An educational in-service was conducted by the manufacturer regarding the table setup, patient transfer and patient safety.The ifu/owner's manual of the table was reviewed for information pertaining to locking the rotation lever and found to be sufficient.This incident is thus deemed as a use error as there was a failure to follow manufacturer's recommended guidelines and recognized best practices for patient safety.
Event or Problem Description
A patient fell during the transfer from the operating table back to the hospital bed.The frame was suspected to be unlocked which caused the patient to fall and hit the floor.

• Brand Name: TRIOS, TABLE 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 ave; union city, CA 94587-1234
• MDR Report Key: 20102414
• Report Number: 2921578-2024-00017
• Device Sequence Number: 8340617
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: (01)00842430103957
• Combination Product (Y/N): N
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7803
• Device Catalogue Number: 7803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Supplement Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown