MAUDE Adverse Event Report: STERIS CORP STERIS 5085 SRT SURGICAL TABLE; TABLE, OPERATING-ROOM

Model Number 5085

Device Problem Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2019

Event Type  malfunction  

Event Description

During a laparoscopic appendectomy the patient was tilted less than ten degrees to the left.As surgeon was finishing the procedure, staff heard a loud metal "snap/pop".Staff saw patient began to shift to his left as the physicians began to brace and hold the patient.Staff assisted and braced patient from sliding further.Patient unharmed, sterility maintained and patient placed on new bed.There was discussion about the loud noise heard prior to the patient falling and this noise was able to be recreated with adding some pressure to the sliding pads as it hit the bed frame.After investigation of how the patient could have started to slide off the bed frame from the operating room table, it was concluded most likely the table pad was not secured in the pegs initially, prior to the patient getting on the bed.If the pegs were engaged in the frame we could not recreate a way for the pads to slide off the frame.There are 4 pegs on each of the plates, 2 of which snap into an opening to receive them and 2 which we believe caused the patient to slide.

• Brand Name: STERIS 5085 SRT SURGICAL TABLE
• Type of Device: TABLE, OPERATING-ROOM
• Manufacturer (Section D): STERIS CORP; 2720 gunter park drive east; montgomery AL 36109
• MDR Report Key: 9395142
• MDR Text Key: 168654108
• Report Number: 9395142
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5085
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 18615 DA