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

Model Number 5803I

Device Problems Fracture (1260); Device Slipped (1584)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/10/2019

Event Type  malfunction  

Event 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
• Type of Device: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• Manufacturer Contact: anne leblanc ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 8824184
• MDR Text Key: 183885005
• Report Number: 2921578-2019-00025
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106002
• UDI-Public: 00842430106002
• Combination Product (y/n): N
• Reporter Country Code: SF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 5803I
• Device Catalogue Number: 5803I
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1