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

Model Number	3085 SP Surgical Table
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	05/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported than an employee was cleaning the shroud guard column protector on a 3085sp surgical table and obtained a cut on their finger.A band-aid was applied; no additional medical treatment was sought.
Additional Manufacturer Narrative
A steris service technician inspected the 3085sp surgical table and observed a burr on the shroud guard column protector.The technician filed down the burr, tested the surgical table, confirmed it to be operational and returned the table to service.A complaint review has determined this event to be isolated.No additional issues have been reported.

• Brand Name: 3085SP 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: 17037700
• Report Number: 1043572-2023-00111
• Device Sequence Number: 6412936
• Product Code: FQO
• UDI-Device Identifier: 00724995155049
• UDI-Public: 00724995155049
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/01/2023

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
• Device Model Number: 3085 SP Surgical Table
• Device Catalogue Number: ST010101
• 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: 05/02/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2016
• 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