MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085 SP SURGICAL TABLE

Model Number	3085 SP Surgical Table
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The medwatch report did not identify the serial number of the table in question and to date, it has not been provided by the user facility.Steris has contacted the user facility requesting additional information regarding the reported event and to inspect the table; however, to date, a response has not been provided.A review of service records does not indicate that steris was contacted regarding the reported event prior to receiving the medwatch report.The user facility reported that the table has been returned to service.It is likely that the reported event is attributed to user error as the floor locks may have been unlocked while the patient was on the table.The 3085 sp surgical table operator manual states (1-1), "warning - tipping hazard: do not place patient on the table unless floor locks are engaged.Do not release floor locks while patient is on table." a follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported via medwatch report # (b)(4), that during a patient procedure, their 3085 sp surgical table began to tip.The table was stabilized, and the procedure was completed successfully.No report of injury or procedure delay.

• Brand Name: 3085 SP 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: 17307116
• Report Number: 1043572-2023-00124
• Device Sequence Number: 20636515
• Product Code: FQO
• UDI-Device Identifier: 00724995155056
• UDI-Public: 00724995155056
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 07/12/2023

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: 3085 SP Surgical Table
• Device Catalogue Number: ST010102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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