MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY SURGIGRAPHIC 6000 IMAGE GUIDED SURGICAL TABLE; SURGIGRAPHIC 6000 TABLE

Model Number SURGIGRAPHIC 6000 TABLE

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/13/2023

Event Type  malfunction  

Event Description

The user facility reported via medwatch report (b)(4), that during a patient procedure their surgigraphic 6000 image guided surgical table would not respond to hand control commands.User facility personnel proceeded to utilize the surgical table and the procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris service technician inspected the surgigraphic 6000 image guided surgical table and found that the power cord to the hand control had a visible cut through it.The technician stated that user facility personnel had run over the cord with the surgical table subsequently causing the damage to the cord from the table's wheel casters.The technician ordered a new hand control for the surgigraphic 6000 image guided surgical table.The operator manual states, "(sec.4.3) - hand (pendant) control - caution - possible equipment damage: hang the hand control from side rail of the table when not in use, to avoid possible damage to the control.".The surgigraphic 6000 image guided surgical table is equipped with emergency back-up buttons should the hand control not respond.The operator manual states (sec.2.4), "emergency backup buttons - three emergency backup buttons are located behind the cover plate on the front left corner of the table base.They may be used the moment the hand control/foot control/palm handle control become lost or damaged.".The operator manual states, "routine maintenance sec.5; sub-section 5.2 maintenance: 1) electrical cords and connectors: ensure all electrical cords and connectors are free of lacerations and/or damage.Ensure there are no exposed wires on any of the pendants.Damaged electrical cords, connectors, and exposed wires will need to be replaced.".The steris service technician counseled user facility personnel on the proper use and operation of the surgigraphic 6000 image guided surgical table specifically, the importance of proper placement of the hand control and the location/operation of the emergency backup buttons.A follow-up report will be submitted upon receipt and install of a new hand control.No additional issues have been reported.

Manufacturer Narrative

The steris service technician installed a new hand control, tested the function and operation of the device and confirmed it to be operating properly.The surgigraphic 6000 image guided surgical table was returned to service and no additional issues have been reported.

• Brand Name: SURGIGRAPHIC 6000 IMAGE GUIDED SURGICAL TABLE
• Type of Device: SURGIGRAPHIC 6000 TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16817265
• MDR Text Key: 314039435
• Report Number: 1043572-2023-00093
• Device Sequence Number: 1
• Product Code: GDC
• UDI-Device Identifier: 00724995155247
• UDI-Public: 00724995155247
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SURGIGRAPHIC 6000 TABLE
• Device Catalogue Number: TA01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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