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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

The user facility contacted steris asking we perform an evaluation of the 4085 surgical table to rule out the equipment as a contributor to the reported event.The user facility stated they were having all equipment inspected in which the patient may have come into contact with that day and is not stating that the 4085 surgical table is the cause of the burn.A steris service technician inspected the 4085 surgical table and found the table to be operating to specifications.No issues were noted with the function or operation.The technician performed electrical testing and tested the electrical connections within the table's base; no issues were noted.The steris service technician returned the table to service, and no additional issues have been reported.

Event Description

The user facility contacted steris to have their 4085 surgical table inspected as a patient received a "burn" following a procedure that was previously performed on their surgical table.The patient received medical treatment.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 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: 18369652
• MDR Text Key: 331073565
• Report Number: 1043572-2023-00168
• Device Sequence Number: 1
• Product Code: FQO
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2023
• 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