MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 3085SP SURGICAL TABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 03/01/2017

Event Type  malfunction  

Manufacturer Narrative

The unit was removed from service.A steris service technician arrived on-site, inspected the unit, and found the table to be operating properly.The table is approximately 19 years old and is not under steris contract for preventative maintenance services.At this time the user facility has not responded to steris' attempts to gain additional information regarding the reported event.A follow-up mdr will be submitted if additional information is obtained.

Event Description

The user facility reported a patient began to slide off their 3085sp surgical table during a patient procedure.

Manufacturer Narrative

During the technician's onsite evaluation of the table, user facility personnel were interviewed regarding the reported event.User facility personnel stated that no injury occurred as a result of the reported event.Contrary to the report of the patient sliding off the table, the patient did not slide as originally reported by user facility personnel.The user facility clarified that the patient's arm began to slide off the table.The patient was repositioned, and the procedure was completed successfully.The technician completed the inspection of the table and found it to be operating properly.The technician identified that the patient was not properly secured during the procedure.The 3085 sp surgical table operator manual states on page 1-2 "warning - personal injury hazard: unanticipated table movement could cause patient injury.Patient must be secured to the table in accordance with recommended positioning practices." the technician reviewed proper positioning practices with the user facility.No additional issues have been reported with the table.

• Brand Name: 3085SP 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: 6443565
• MDR Text Key: 71466256
• Report Number: 1043572-2017-00019
• 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,Followup
• Report Date: 03/29/2017

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: 03/02/2017
• Initial Date FDA Received: 03/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/05/2017
• 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