MAUDE Adverse Event Report: MIZUHO AMERICA INC. / MIZUHO ORTHOPEDIC SYSTEMS, INC. HANA ORTHOPEDIC SURGERY TABLE; TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED

Model Number 6875

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  malfunction  

Event Description

Hana orthopedic surgery table would not function even after thorough troubleshooting.Fda safety report id # (b)(4).

• Brand Name: HANA ORTHOPEDIC SURGERY TABLE
• Type of Device: TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, AC-POWERED
• Manufacturer (Section D): MIZUHO AMERICA INC. / MIZUHO ORTHOPEDIC SYSTEMS, INC.; union city CA 94587
• MDR Report Key: 12916892
• MDR Text Key: 281689598
• Report Number: MW5105726
• Device Sequence Number: 1
• Product Code: JEA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White