MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA; OPERATING SURGICAL TABLE

Model Number 6875

Device Problems Loose or Intermittent Connection (1371); Electrical Shorting (2926); Unintended Movement (3026)

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

Event Date 05/31/2019

Event Type  malfunction  

Event Description

It was reported while used in surgery, raised the table using the hand control.Could not stop the table from raising, it just keep raising and the patient got pressed up against the c-arm.Managed to move the c-arm away and patient was moved away from the table.

Manufacturer Narrative

The root cause was most likely the connector on the pendant, which was badly damaged.It is unknown if the table went thru a pre-inspection which would have seen the broken connector on the hand pendant.If hit the "emergency stop button" would have immediately halted all table movement.Owner's manual says in section 4.2 general inspection, before use, inspect the device for possible damage, excessive wear, or non-functioning parts.Visually inspect all accessible areas, electrical cords, and all movable parts for possible damage that may adversely affect the proper operation of the hana® orthopedic surgery table.Damaged or defective products should not be used or processed.

Event Description

It was reported while used in surgery, raised the table using the hand control.Could not stop the table from raising, it just keep raising and the patient got pressed up against the c-arm.Managed to moved the c-arm away and patient was moved away from the table.

• Brand Name: HANA
• Type of Device: OPERATING SURGICAL TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 8666174
• MDR Text Key: 146918488
• Report Number: 2921578-2019-00023
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1