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

Model Number	6875
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Handling Problem (3265)
Health Effect - Clinical Codes	Abrasion (1689); Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946); Vertebral Fracture (4520); Insufficient Information (4580)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the top of the table moved 2 plus inches in an airplane fashion during surgery.The patient fell off the bed and sustained injury.
Event or Problem Description
It was reported that the top of the table moved 2 plus inches in an airplane fashion during surgery.The patient fell off the bed and sustained injury.Patient received a laceration on the head which was cleaned and dressed.No stitches were needed.Ct scanning was done from head on down.The only additional injury found was a possible fracture at l1.Patient passed away one week after the surgery ((b)(6) 2022) and it was reported to mizuho osi on (b)(6) 2022.Medical status of the patient prior to incident: the patient had a lengthy medical history including cardiovascular disease, alzheimer's and previous falls.The femoral injury happened in a fall at home for which the patient was being operated for.
Additional Manufacturer Narrative
Based on the information received from the investigation, the patient was secured using 3-inch silk tape and not the safety strap as mentioned in the instructions for use that might have contributed to the patient fall.Device evaluation by the field service engineer and hospital personnel could not reproduce the problem as initially reported.On (b)(6) 2022 it was reported to mizuho osi that the patient died one week after the surgery on (b)(6) 2022.The investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.It is unknown if the operating room fall may have contributed to the patient death, or if it was due to the broken bone and surgery on top of the patient's already fragile condition.

• 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 avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 15189157
• Report Number: 2921578-2022-00013
• Device Sequence Number: 14838184
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2022

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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
• Outcome Attributed to Adverse Event: Other; Death; Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 125 KG