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

Model Number 6875

Device Problems Insufficient Information (3190); Device Handling Problem (3265)

Patient Problems Abrasion (1689); Bruise/Contusion (1754); Fall (1848); Laceration(s) (1946); Vertebral Fracture (4520); Insufficient Information (4580)

Event Date 08/04/2022

Event Type  Injury  

Event 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 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.

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
• Type of Device: 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
• MDR Text Key: 305076308
• Report Number: 2921578-2022-00013
• Device Sequence Number: 1
• Product Code: JEA
• UDI-Device Identifier: 00842430108747
• UDI-Public: 00842430108747
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Death; Hospitalization; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male
• Patient Weight: 125 KG