MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE DC INTERNATIONAL; SURGICAL OPERATING TABLE

Model Number	5803I
Medical Device Problem Codes	Fracture (1260); Device Slipped (1584)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported; the base is reported to have suffered a catastrophic failure.During the procedure on sunday 10 march the surgeon requested screening with the c-arm.The c-arm was positioned and while screening took place, a loud "clicking" noise was audible coming from the head of the table.After the arm was removed and the procedure continued, another loud noise (as if a mechanical part break) was heard and the table tilted to the right.The surgeons managed to stop the tilting action.To secure the top, the bed was elevated and two wound trolleys placed below the surface and board.It was slowly lowered to the touching point and the procedure commenced.The patient was transferred to an alternative procedure table and the procedure continued.Due to the e-ring falling out which allowed the shaft to move out of place and as the shaft moved freely downward it caused an angled force which caused the casing mount on the tilt motor assembly on the motor to break.To date, mizuho osi has never seen this type of failure during normal use.Also, it was observed in the preventative maintenance report, that the checklist was not completed, indicating that they were not performed, or they did not pass.If these mandatory and critical steps in the preventative maintenance had been conducted there is a probability that the issue with the tilt actuator may have been discovered.It is not known how the e-ring became unlatched from the shaft of the tilt actuator, however this appears to be an isolated incident.

• Brand Name: ADVANCED CONTROL I-BASE DC INTERNATIONAL
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8824184
• Report Number: 2921578-2019-00025
• Device Sequence Number: 16853844
• Product Code: JEA
• UDI-Device Identifier: 00842430106002
• UDI-Public: 00842430106002
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2019

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: 5803I
• Device Catalogue Number: 5803I
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1