MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3080RL SURGICAL TABLE

Device Problems Self-Activation or Keying (1557); Positioning Problem (3009)

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

Event Date 05/28/2015

Event Type  No Answer Provided  

Event Description

The user facility reported that with a patient positioned on their 3080rl surgical table, hospital personnel commanded the table's leg section up via the hand control however, the leg section moved downward.Hospital personnel utilized the override auxiliary switches and commanded the table into the desired position.The procedure was completed successfully.No report of injury.

Manufacturer Narrative

A steris service technician arrived onsite and was unable to evaluate the hand control subject of the reported event.As the hand control was not available for evaluation the technician was not able to confirm if it was operating properly.The technician utilized another hand control and confirmed the table to be operating properly when table positions were commanded.The technician further inspected the table and found it to be operating properly.The table was tested with weight and no issues were noted.The table was returned to service and no additional issues have been reported.Hospital personnel followed proper operating procedures by utilizing the table's override switches.The table operated as designed to allow hospital personnel to command the table into the desired position via the override switches in the event the primary controls are not operating properly.The operator manual states, (pp.5-1), "the 3080-r remanufactured amsco® surgical table is equipped with auxiliary override systems that can be actuated at any time and that will allow table operation in the event of primary control malfunction." the steris account manager received a phone call from the user facility's surgical services coordinator stating she spoke with the or director who disclosed that the reported event likely occurred due to "user error".Steris offered in-service training on the proper use and operation of the surgical table.

• Brand Name: 3080RL 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: 4868649
• MDR Text Key: 19023838
• Report Number: 1043572-2015-00061
• 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: 06/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• 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: 05/28/2015
• 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
• Patient Outcome(s): Other