MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TABLE, HANA, 110 V; OPERATING TABLE

Model Number	6875
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient being transferred from hana table to the patient bed after surgery fell off the table.The staff did not put the perineal post in to stabilize the patient.Scans were taken to make sure the patient was ok and the tests came back negative.Patient has since been deceased, however not due to surgery or any complications due to the fall.
Event or Problem Description
Patient being transferred from hana table to the patient bed after surgery fell off the table.The staff did not put the perineal post in to stabilize the patient.Scans were taken to make sure the patient was ok and the tests came back negative.Patient has since been deceased, however not due to surgery or any complications due to the fall.
Additional Manufacturer Narrative
Per the information obtained from the investigation, no problems were reported with the device.Patient underwent ct scan following the fall and no injuries were observed/reported by the hospital.During the interview of hospital personnel, it was learned that the safety straps were not used during or after surgery.The usage of safety straps is clearly noted in the product owner's manual/ifu along with the warnings pertaining to patient safety.This incident is thus deemed as use error as there was a failure to follow recommended guideline and safety practices as recognized by manufacturer in the instructions for use.

• Brand Name: TABLE, HANA, 110 V
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern ave; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern ave; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 19354336
• Report Number: 2921578-2024-00003
• Device Sequence Number: 12644428
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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?: No
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/29/2017
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown