MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MODULAR TABLE ADVANCED CONTROL "I" BASE, 100V; SURGICAL OPERATING TABLE

Model Number	5803J
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during spinal surgery, the orthopedic doctor instructed the anesthesiology trainee to tilt action.However, the hand pendant did not respond because the 180 degree rotation lock blue handle (head side) was unlocked for some reason.While the anesthesiology trainee suspected a problem and was operating various operations, he pressed the rotation safety lock switch (leg side).At that moment, the 180[?] rotation lock was completely unlocked, the table rotated under the patient's own weight and the patient fell from head to the floor.
Event or Problem Description
It was reported, during spinal surgery, the orthopedic doctor instructed the anesthesiology trainee to tilt action.However, the hand pendant did not respond because the 180 degree rotation lock blue handle (head side) was unlocked for some reason.While the anesthesiology trainee suspected a problem and was operating various operations, he pressed the rotation safety lock switch (leg side).At that moment, the 180 degree rotation lock was completely unlocked, the table rotated under the patient's own weight and the patient fell from head to the floor.
Additional Manufacturer Narrative
There is no failure of a device to meet its performance specifications; device performed as intended.Root cause of this issue is operator error (not following product manual instructions).Nw0646 rev h "owner's manual 5803 advanced control base" document contains adequate caution and warning notes to ensure safe device operation.Follow-up training was provided to hospital staff involved with this issue.

• Brand Name: MODULAR TABLE ADVANCED CONTROL "I" BASE, 100V
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11011169
• Report Number: 2921578-2020-00032
• Device Sequence Number: 753425
• Product Code: JEA
• UDI-Device Identifier: 00842430107016
• UDI-Public: 00842430107016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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: 5803J
• Device Catalogue Number: 5803J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/10/2020
• Supplement Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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: Hospitalization
• Patient Weight: 110