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

Device Problem Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 09/29/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the table and found the table's floor lock feet were too close to the floor resulting in the table not being able to re-lock.The technician adjusted the table's feet to the correct height, tested the unit, confirmed it was operating according to specifications, and returned it to service.The reported event is attributed to user error as facility personnel should not have unlocked the 3085 sp surgical table while a patient was on the table.The 3085 sp surgical table operator manual states (1-1), "warning - tipping hazard: do not place patient on the table unless floor locks are engaged.Do not release floor locks while patient is on table." the technician counseled user facility personnel including the doctor on the proper use and operation of their 3085 sp surgical table, specifically to not release the floor locks while a patient is on the table.No additional issues have been reported.

Event Description

The user facility reported that during a patient procedure their 3085 sp surgical table would not re-lock once unlocked with patient on top of the table.The patient was transferred to a different table resulting in a procedure delay; the procedure was completed successfully.No report of injury.

• Brand Name: 3085 SP 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: 10747922
• MDR Text Key: 215076023
• Report Number: 1043572-2020-00051
• 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: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• 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: 09/30/2020
• 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