MAUDE Adverse Event Report: MIZUHO OSI ADVANCED CONTROL I-BASE, DC; OPERATING TABLE

Model Number 5803

Device Problem Unintended Movement (3026)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that mizuho osi table was being used with a mapping system and staff unlocked the table to roll it but patient rolled off the table in doing so.

Manufacturer Narrative

Based on the information received from the investigation, it was deemed as a user error as there was misuse of mizuho osi table along with mazor x steath (non-mizuho osi product) contrary to published instructions by mazor/medtronic that mentioned "the surgical table movement feature must be disabled during surgery with the mazor x stealth edition surgical system".Table was actively tilted with the mazor x arm attached, which caused failure of the tilt actuator due to the excess movement load imparted by the mazor x stealth robot system/arm.It is also believed that there was a misuse by lack of regular preventative maintenance of a table that is 14+ years old along with of documented yearly preventative maintenance.The adjustment of the head and foot end brakes was also found to be non-compliant with the specifications mentioned in the owner's manual.

Event Description

It was reported that mizuho osi table was being used with a mapping system and staff unlocked the table to roll it but patient rolled off the table in doing so.No reported patient injury.Hospital staff slowly lowered the patient to the ground.The patient was lifted back to another bed for imaging and safety precautions.Case was cancelled and rescheduled for next day.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Type of Device: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15901487
• MDR Text Key: 306882788
• Report Number: 2921578-2022-00024
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430106026
• UDI-Public: 00842430106026
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2008
• 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