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

Device Problem Inadequate User Interface (2958)

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

Event Date 08/16/2018

Event Type  malfunction  

Manufacturer Narrative

During the time of the reported event, the user facility attempted to utilize the hand control several times to move the surgical table into the desired position; however, the table would only tilt left.A steris service technician arrived onsite to inspect the table and hand control subject of the event.The technician observed that the hand control cable was visibly hanging from the bottom of the table.The technician removed the shroud covers and identified that the hand control cables had been misrouted.The cables had contacted the components within the table's column causing the cables to become damaged (cut) and the reported event to occur.The technician repaired the hand control's cables, tested the hand control and table, confirmed them to be operating according to specifications, and returned the table and hand control to service.While onsite, the technician learned that user facility personnel had a third-party servicer install the hand control.The technician counseled the user facility on the importance of proper service and installation activities.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure, their 4085 surgical table would not respond to hand control commands.A procedure delay occurred as the patient was safely transferred to another surgical table.The procedure was completed successfully, and no injuries were reported.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: 4085 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: 7868339
• MDR Text Key: 120255923
• Report Number: 1043572-2018-00070
• 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: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/17/2018
• Initial Date FDA Received: 09/12/2018
• 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