MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

Model Number	4085 Surgical Table
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite and discussed the reported event with user facility personnel who were present during the patient procedure.User facility personnel stated that the 4085 surgical table was in reverse orientation with the patient's position prone (face down).The surgical table was slid to full extension in the head direction with the tabletop level.It was observed that the patient's head/torso were slightly below level.Following the observation of the patient's position, the user commanded the table via the hand control to return to level however, the table section with the patient's head/torso began to lower.The table was then commanded to raise back up to level however, the table did not respond.As the table would not respond, user facility personnel transferred the patient to a different surgical table.The steris service technician inspected the table and was unable to duplicate the reported event.In addition, the technician found damage to the right hand lateral (seat section) cover and leg end cover.The technician repaired the 4085 surgical table, tested the table, and confirmed it to be operating properly.The surgical table was returned to service and no additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure the back section of their 4085 surgical table lowered in height without being commanded to do so.The patient was transferred to another surgical table subsequently causing a procedure delay.The procedure was completed successfully, and no injuries were reported.

• Brand Name: 4085 SURGICAL TABLE
• Common Device Name: SURGICAL 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: 15977518
• Report Number: 1043572-2022-00087
• Device Sequence Number: 17866049
• Product Code: FQO
• UDI-Device Identifier: 00724995154783
• UDI-Public: 00724995154783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: 4085 Surgical Table
• Device Catalogue Number: ST013507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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