MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY BARIATRIC EXTENSION TO 3085 SURGICAL TABLE

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem Injury (2348)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the armboard, bariatric extension, and 3085 surgical table.The technician found both accessories to be operating according to specification; no repairs were required.While onsite, the technician learned that facility personnel did not tighten the clamp to secure the bariatric extension to the surgical table as stated in the operator manual.The reported event is attributed to user error.The bariatric extension operator manual (1-1) states, "warning - personal injury and/or equipment damage hazard: to prevent patient and/or user injury and/or equipment damage, assure bariatric table extensions attaching clamps fully contact table side rails and are securely tightened in place.Test locking to ensure no extension movement when listed or pushed." the operator manual (2-3) further states, "4.Tighten extension side rail clamp by rotating clamp locking handle clockwise." the technician counseled facility personnel on the proper use and operation of the bariatric extensions.No additional issues have been reported.

Event Description

The user facility reported that an employee obtained an injury as a bariatric extension with an armboard attached had detached from their 3085 surgical table and fell on the employee's foot.Medical treatment was sought.There was no patient present during the time of the reported event.

• Brand Name: BARIATRIC EXTENSION TO 3085 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: 8874554
• MDR Text Key: 208964459
• Report Number: 1043572-2019-00067
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2019
• 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