MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. MODULAR TABLE SYSTEM; SURGICAL TABLE

Model Number 5803

Device Problems Device Slipped (1584); Device Issue (2379)

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

Event Type  malfunction  

Manufacturer Narrative

There was no record of the required preventive maintenance being performed.In addition, it appears that the site did not do a functional test before prepping patient to ensure table was properly functioning and ready for next patient, which should be standard procedure per the 5803 owner's manual, section 5.2 pre-procedure/post procedure, which states, "before and after each use of the advanced control system, visually inspect all accessible areas, electrical cords and all movable parts for possible damage that may adversely affect the proper operation of the base.Damaged and effective products should not be used or processed".If a proper functional test would have been conducted before the procedure, and it would have failed lateral roll and gone past the 25-degree maximum and most likely would of went to 90-degree tilt, indicating a failure in the tilt actuator located in the head-end assembly, thus rendering the table unusable before the procedure and to not oprep patients for use on this table until the issue was resolved.

Event Description

Integra (b)(4) service technician was called to conduct a pm on a broken 5803 table.When the service tech arrived on site he was advised that while the patient was being prepped for the surgery, a member of the staff had sat on the table and it collapsed under her.There was no injury to the patient or staff member; however, there was the potential for the patient to have been injured if the staff member hadn't sat on the table first.

• Brand Name: MODULAR TABLE SYSTEM
• Type of Device: SURGICAL 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: 7536731
• MDR Text Key: 109003184
• Report Number: 2921578-2018-00016
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5803
• Device Catalogue Number: 5803
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1