MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY OT1100 SURGICAL TABLE

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/11/2017

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived at the facility following the event and inspected the ot1100 surgical table including the gross traction mechanisms.The technician's evaluation identified that one of the gross tracking locking mechanisms had loosened preventing the device from consistently locking into position.The technician was informed that during the reported event, the facility was able to correctly lock the gross tracking mechanism into position after the initial attempt; the procedure was completed successfully.The technician replaced the table's gross traction locking mechanisms, tested the table and returned the unit to service.

Event Description

The user facility reported that during a patient procedure, the gross traction assembly did not operate as designed.The procedure was successfully completed by the surgical staff.No injuries to patient or staff were reported.

• Brand Name: OT1100 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6622387
• MDR Text Key: 77300526
• Report Number: 1043572-2017-00039
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2017
• 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: 05/11/2017
• 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