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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite and discussed the reported event with user facility personnel.User facility personnel stated that the patient was in a prone (face down) position and was not strapped to the table causing the reported event to occur.Additionally, the technician found that the table had excessive lash, and a few of the siderail fasteners were not securely tightened.The technician made the necessary adjustments, tested the table, confirmed to be operational, and returned it to service.The 4085 surgical table was manufactured in 2011 and is not under a steris service contract.The user facility is responsible for all maintenance activities.The 4085 surgical table operator manual states (1-2), "warning - personal injury hazard: failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury." the operator manual further states (1-2), "warning - personal injury hazard: patient must be secured to the table in accordance with recommended positioning practices.Unanticipated patient or table movement could result in death or serious injury." steris account manager contacted the customer and offered in-service training, and is pending a response.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that during a patient procedure the patient slid off the 4085 surgical table onto the floor.The user facility stated that the back of the table "popped up" as the patient was lowered to the floor.Details of injury were not disclosed.The table was removed from service and the procedure was cancelled.
Additional Manufacturer Narrative
A steris account manager offered in-service training to the user facility; however, the user facility declined.No additional issues have been reported.
Additional Manufacturer Narrative
Udi related data quality updates only - the device subject of the event was manufactured prior to udi compliance, therefore, udi is not applicable and was not included in the mdr.

• 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
• MDR Report Key: 18066614
• Report Number: 1043572-2023-00158
• Device Sequence Number: 18084885
• Product Code: FQO
• UDI-Device Identifier: 00724995154776
• UDI-Public: 00724995154776
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/03/2023

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
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023; Not provided
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 12/15/2023; 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2011
• 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