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

Device Problem Positioning Problem (3009)

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

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the surgical table.The technician was informed that after the patient procedure, an employee tried to lower the surgical table, so they could transfer the patient from the surgical table to a transport bed.The table would not lower, so the employees lifted the patient from the surgical table to the transport bed.The technician inspected the surgical table and found that the table's column cover was damaged and misaligned.The facility declined repairs from the technician and the surgical table has not been returned to service.The 3085sp surgical table was installed in 1998 making this unit approximately 20 years old and is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The 3085sp surgical table operator manual (1-2) states: "safe and reliable operation of this equipment requires regularly scheduled preventative maintenance, in addition to the faithful performance of routine maintenance.Contact steris to scheduled preventative maintenance." additionally, the 3085sp surgical table operator manual (1-2) states: "repairs and adjustments to this equipment must be made only by fully qualified service personnel.Nonroutine maintenance performed by inexperienced, unqualified personnel or installation of unauthorized parts could cause personnel injury, invalidate the warranty, or result in costly damage.Contact steris for service options." no additional issues have been reported.

Event Description

The user facility reported that their 3085sp surgical table would not lower to the desired height at the end of a patient procedure.No injury or procedure delay was reported.

• 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8075566
• MDR Text Key: 129068829
• Report Number: 1043572-2018-00092
• 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: 11/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2018
• 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: 10/18/2018
• 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