MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MTS SPINAL SURGERY TOP; SURGICAL OPERATING TABLE

Model Number	5943
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Fall (1848)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported a patient fall during a case due to the anesthesiologists setting his hand on the top of the mts and pressing the blue tilt lock button.He said the blue knob on the side wasn't tightened and the anesthesiologists rested his hand on the top of the column hitting the blue button and the patient fell off when the top tilted.
Additional Manufacturer Narrative
Based on the investigation it is concluded that the user/operator did not follow the instructions/warning as specified in the owner's manual.Customer error is the contributing factor owner's manual, 5803 advanced control (nw0646 rev.H).The table behaved as designed, the blue rotation lock handle was loose, the anesthesiologist set his hand on the rotation safety lock which when fully released the table causing it to rotate the owner's manual nw0646 has ample descriptions and warning on how to unlock functions: section 4.5 indicator lights.Warning: failure to ensure that all three blue indicator lights are illuminated prior to patient transfer may result in harm to the patient, healthcare workers, or the device.Warning: when the 180 degree rotation lock indicator light is not illuminated, the table top is unlocked regardless of how much the blue handle has been turned clockwise or counterclockwise.Section 4.5.2 rotation safety lock.Warning: failure to ensure that the 180 degree rotation lock and the rotation safety lock are locked with the corresponding blue indicator lights on both the head-end column and hand pendant illuminated may result in harm to the patient, healthcare workers or device.When the 180 degree rotation lock and the rotation safety lock are both engaged and the corresponding indicator lights are illuminated, the table top can still be laterally rolled (tilted) by pressing the left or right lateral roll button on the hand pendant until the desired position is achieved.
Event or Problem Description
It was reported a patient fall during a case due to the anesthesiologists setting his hand on the top of the mts and pressing the blue tilt lock button.He said the blue knob on the side wasn't tightened and the anesthesiologists rested his hand on the top of the column hitting the blue button and the patient fell off when the top tilted.

• Brand Name: MTS SPINAL SURGERY TOP
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11366186
• Report Number: 2921578-2021-00005
• Device Sequence Number: 14475328
• Product Code: JEA
• UDI-Device Identifier: 00842430105982
• UDI-Public: 00842430105982
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 04/29/2021

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: Health Professional
• Device Model Number: 5943
• Device Catalogue Number: 5943
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2021
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1