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

Device Problem Positioning Problem (3009)

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

Event Date 04/10/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that during a patient procedure with their 4085 surgical table at a slight tilt position, the patient shifted.No report of injury or procedural delays or cancellations.

Manufacturer Narrative

A steris service technician inspected the table and found that multiple table top sections were missing x-ray top metal grommets.The technician further noted that the slide position on the hand control was displaying the position inaccurately and fluctuating.During the time of the reported event the surgical table had x-ray tops installed.The technician replaced the slide sensor, tested the table and confirmed it to be operating properly.No additional issues have been reported.The user facility is in the process of ordering new table tops.Once the table tops are received the user facility will replace the existing table tops and x-ray top metal grommets.The table is not under steris service contract and is service and maintained by the user facility.The operator manual states (pp.5-7), "remove and inspect x-ray tops on each table section (if equipped) 1 x per year." in addition, the operator manual states (pp.2-3), "patient positioning and weight limitation- note: when positioning the patient on the table, note the following: 4) ensure all accessories are properly installed and secured.".

• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4753250
• MDR Text Key: 19407667
• Report Number: 1043572-2015-00040
• 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: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2015
• 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: 04/10/2015
• 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