MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 4085 SURGICAL TABLE

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

Patient Problem Bruise/Contusion (1754)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the 4085 surgical table and found no issue with the function or operation of the table.No repairs were required, and the table was returned to service.At the time of the reported event, a safety strap was positioned across the patient's waist.After speaking with user facility personnel, the technician determined that the patient had not been properly secured to the table subsequently causing the reported event to occur.The 4085 surgical table operator manual states (1-2), "warning - personal injury hazard: failure to keep the patient properly secured with the patient safety straps at all times could result in death or serious injury." the operator manual further states (1-2), "warning - personal injury hazard: patient must be secured to the table in accordance with recommended positioning practices.Unanticipated patient or table movement could result in death or serious injury." no additional issues have been reported.

Event Description

The user facility reported that during a patient procedure user facility personnel commanded their 4085 surgical table to left tilt when the patient began sliding off the table.The patient was repositioned on the table resulting in a procedure delay; the procedure was completed successfully.The patient had minor scratches on their shoulder as a result of the reported event.No medical treatment was administered.

• Brand Name: 4085 SURGICAL TABLE
• Type of Device: SURGICAL TABLE
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery, al
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, oh ; 3927453
• MDR Report Key: 10165127
• MDR Text Key: 202397911
• Report Number: 1043572-2020-00027
• 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: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• 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: 05/22/2020
• 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