MAUDE Adverse Event Report: MIZUHO OSI HANA; OPERATING TABLE

Model Number	6875
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
In the middle of surgery the leg joint lock broke and it fell to the floor.
Additional Manufacturer Narrative
Evaluation of the device found broken parts inside, likely fatigue fractures due to repeated over-torquing of the brake by the users.
Event or Problem Description
In the middle of surgery the leg joint lock broke and it fell to the floor.

• Brand Name: HANA
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 12820749
• Report Number: 2921578-2021-00026
• Device Sequence Number: 20237791
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: 6875
• Device Catalogue Number: 6875
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 11/10/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown