MAUDE Adverse Event Report: MIZUHO ORTHOPEDIC SYSTEMS, INC. TRIOS, TABLE BASE; OPERATING TABLE

Model Number	7803
Medical Device Problem Code	Unintended System Motion (1430)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
While patient was on the table, the trios table system began shaking or "sputtering" uncontrollably.The sputtering was excessive enough during this latest episode that the team in the room thought the patient may fall off the table.Sputtering occured intermittently until it got to 39 inches and up when it became its worst.
Event or Problem Description
While patient was on the table, the trios table system began shaking or "sputtering" uncontrollably.The sputtering was excessive enough during this latest episode that the team in the room thought the patient may fall off the table.Sputtering occured intermittently until it got to 39 inches and up when it became its worst.
Additional Manufacturer Narrative
Per the information obtained from investigation and device evaluation, an intermittent pausing of the table column after 36" along with low voltage of the batteries was observed.After performing the column calibration and battery re-charge, the reported issue of "sputtering" or "shaking" was not observed/reproduced.Potentiometer, batteries and power cord were replaced by the manufacturer following the incident.

• Brand Name: TRIOS, TABLE BASE
• 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: 19982449
• Report Number: 2921578-2024-00013
• Device Sequence Number: 11453155
• Product Code: JEA
• UDI-Device Identifier: 00842430103957
• UDI-Public: (01)00842430103957(21)1000
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7803
• Device Catalogue Number: 7803
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2018
• 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
• Patient Sex: Unknown