MAUDE Adverse Event Report: MIZUHO OSI TABLE, HANA, 110 V; OPERATING TABLE

Model Number	6875
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Limb Fracture (4518); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported in fda medwatch report # mw5117644- "equipment malfunction.".
Additional Manufacturer Narrative
Based on the information obtained from investigation and device evaluation, there were no issues found with the device that could have caused or contributed to the patient injury.Following the service request, the table passed all the operational safety checks and was ready to be used.It is suspected that the root cause might be user error pointing towards incorrect locking of leg spar.Prior to the use on patient despite the warnings mentioned in the owner's manual- :"failure to lock the spar lock handle can cause the spar to drop when not held in place, which could result in damage to the table, possible injury to the patient or har to the healthcare professionals".
Event or Problem Description
As reported in fda medwatch report # mw5117644- "equipment malfunction".As communicated by hospital personnel- after positioning the patient for surgery, the leg dropped to the floor.The patient sustained additional fractures to the operative leg which required the surgeon to change plan for surgical intervention to the patient.The patient was able to be transferred to a rehab facility and was doing well.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: 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 ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 17043765
• Report Number: 2921578-2023-00007
• Device Sequence Number: 13026255
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2015
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female