MAUDE Adverse Event Report: MIZUHO OSI MODULAR TABLE SYSTEM; OPERATING TABLE

Model Number	5803I
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Reported that a patient fell off the table.
Additional Manufacturer Narrative
There was apparently no injury.No further information could be obtained.Unclear if the reporter witnessed the event.The reporter was unable or unwilling to describe how the event occurred.Some kind of human error is suspected.
Event or Problem Description
Reported that a patient fell off the table.

• Brand Name: MODULAR TABLE SYSTEM
• Common Device Name: OPERATING TABLE
• Manufacturer (Section D): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer (Section G): MIZUHO OSI; 30031 ahern av; union city CA 94587 1234
• Manufacturer Contact: krina shah ; 30031 ahern avenue; union city, CA 94587-1234 ; 5104291500
• MDR Report Key: 12801293
• Report Number: 2921578-2021-00024
• Device Sequence Number: 20028214
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2021
• Supplement Date Received by Manufacturer: 11/08/2021
• Initial Report FDA Received Date: 11/11/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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