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

Device Problems Unintended Head Motion (1284); Positioning Problem (3009)

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

Event Date 02/06/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that with a patient positioned on the surgical table, prior to a surgical procedure, the head section of the surgical table failed to hold position and dropped down.The patient was transferred to another surgical table and the procedure was completed successfully.

Manufacturer Narrative

No injuries or procedural delays or cancellations were reported.At the time the event was reported to steris, the customer reported one of the locking pins from the head section of the table was missing.A steris service technician arrived at the facility, inspected the surgical table and found one of the two head section locking pins had come loose causing the head section of the table to drop down as reported.The technician re-secured the pin, tested the surgical table and confirmed the table was operating according to specification.While onsite, the steris technician was informed by hospital personnel that the facility moves the surgical table from one location to the next by pulling on the head section of the table.The technician informed the customer that the reported pulling motion on the head section may have attributed to the pin coming loose over time and instructed the facility not to move the table by pulling on the head section.No further issues have been 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4571973
• MDR Text Key: 5552901
• Report Number: 1043572-2015-00021
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/06/2015
• 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