MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. ADVANCED CONTROL I-BASE, DC; SURGICAL OPERATING TABLE

Model Number	5803I
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was rotated on the jackson table into the supine position when the staff went to remove the hframe and t pins they incorrectly removed the wrong t pin causing the patient to fall off the table.This was a user error not a issue with the table, however they have reported the incident as they require a service engineer to confirm the table is inworking order, a preventative maintenance request has been instigated for the hospital.
Additional Manufacturer Narrative
The issue that caused the patient to fall of the table is due to "user error" of staff pulling the t-pin from the h-frame while a patient was on the table.Hospital will not release any information about condition of patient.As stated in the 5803 owner's manual rev h., section 6.2 installing a table top using h-frames, page 34 shows a yellow waring sign with the following statement, "t-pins extended through the crossbars and table top supporting the patient should never be removed with the patient on the table top.Removing these t-pins may result in harm to the patient, healthcare workers or the devise.
Event or Problem Description
It was reported that the patient was rotated on the jackson table into the supine position when the staff went to remove the h-frame and t pins they incorrectly removed the wrong t pin causing the patient to fall off the table.This was a user error not a issue with the table, however they have reported the incident as they require a service engineer to confirm the table is in working order, a preventative maintenance request has been instigated for the hospital.

• Brand Name: ADVANCED CONTROL I-BASE, DC
• Common Device Name: SURGICAL OPERATING TABLE
• Manufacturer (Section D): MIZUHO ORTHOPEDIC SYSTEMS, INC.; 30031 ahern avenue; union city CA 94587 1234
• MDR Report Key: 11494332
• Report Number: 2921578-2021-00007
• Device Sequence Number: 14744932
• Product Code: JEA
• UDI-Device Identifier: 00842430106002
• UDI-Public: 00842430106002
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2021

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: 5803I
• Device Catalogue Number: 5803I
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 03/11/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other