MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY FEATHERWEIGHT LEG SECTION TO 4085 SURGICAL TABLE

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 4085 surgical table and found the table to be operating properly; no repairs were required.The reported event could not be duplicated.The reported event can be attributed to user error as the featherweight leg section was not properly attached to the table.A steris account manager performed in-service training on the proper use and operation of the 4085 surgical table and the featherweight leg section.No additional issues have been reported.

Event Description

The user facility reported that while transferring a patient to a transfer bed from their 4085 surgical table the featherweight leg section disengaged from the table.A procedure delay was reported for the next case as the user facility brought in a replacement table.

• Brand Name: FEATHERWEIGHT LEG SECTION TO 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: 8181171
• MDR Text Key: 131384560
• Report Number: 1043572-2018-00103
• 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,Followup
• Report Date: 12/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• 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: 11/28/2018
• 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