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

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

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Manufacturer Narrative

A steris account manager inspected the tables and confirmed the sharp edges on the shrouds of the surgical tables that could have resulted in the reported injuries.The tables are approximately 13 years old and not under steris service agreement; the user facility is responsible for all maintenance activities.Based on the description of the event and the account manager's inspection, the reported event is likely attributed to user facility personnel causing damage to the table's shrouds resulting in the sharp edges.The cmax surgical table operator manual states per the preventive maintenance checklist that the table shrouds should be checked for damage two times per year at a minimum.The cmax surgical table operator manual states (1-3), "warning - personal injury and/or equipment damage hazard: regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment.Contact steris to schedule preventive maintenance." steris provided the user facility with a quote to repair the column shrouds.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that employees have obtained cuts on their fingers from the column shrouds of their cmax surgical tables during cleaning activities.No report of medical treatment administered.

• Brand Name: CMAX 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: 11036222
• MDR Text Key: 241008710
• Report Number: 1043572-2020-00064
• Device Sequence Number: 1
• Product Code: GDC
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• 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: 11/19/2020
• 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