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

Device Problems Moisture Damage (1405); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Following the event, user facility personnel removed power from the 4085 surgical table until a steris service technician arrived onsite.A steris service technician arrived onsite to inspect the 4085 surgical table.While onsite, the technician was informed that user facility personnel had not detected smoke until after the procedure was completed, and the patient had been transferred off the table.Upon inspection of the 4085 surgical table, the technician found evidence of fluid intrusion that caused damage to the table's power supply.The technician completed the necessary repairs including replacement of the power supply.The technician tested the table and found it to be operating according to specification.Furthermore, the technician was informed that in this event, the patient procedure that was being performed was a "very wet case", meaning the procedure was fluid intensive.4085 surgical tables are labeled for ipx4 fluid resistance standards as classified in and tested per standard iec 529 60601-2-46.The introduction to the steris 4085 general surgical table operator manual, iii, states: "splash-proof equipment (enclosed equipment protected against splashing water, ipx4)." in the event the amount of fluid present during the procedure exceeds that for the ipx4 rating, it is at the hospital's discretion to ensure the table is properly draped and/or a fluid catchment device is utilized to limit the amount of fluid that may come in contact with the 4085 surgical table.The table subject of the reported event was installed in june of 2013 and is not under steris service contract agreement.No additional issues have been reported.

Event Description

The user facility reported their 4085 surgical table was smoking at the end of a completed procedure.No injury, procedure delay or cancellation was reported.

• 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 ; 4403927453
• MDR Report Key: 7687681
• MDR Text Key: 114424864
• Report Number: 1043572-2018-00055
• 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: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2018
• 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