MAUDE Adverse Event Report: SKYTRON, LLC SURGICAL BED HAND CONTROL; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 3600 SERIES

Device Problems Unintended System Motion (1430); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

While preparing the bed for robotic surgery, the bed moved up by itself without pressing the button.Later in testing the problem was eventually duplicated.It seems the button on the hand control can get stuck on if pressed in the right manner.Under the keypad overlay, there is a small disk shaped piece of plastic that goes between the overlay and the actual button switch.If the button is pressed near the edge, it is possible for the disk to get jammed in the hole and make the switch stick on.While difficult to duplicate, we have seen this issue numerous times in the past.If this were to occur during a robotic surgery it could be extremely dangerous.Manufacturer response for surgical bed hand control, skytron (per site reporter).From previous incident they recommended replacing suspect hand controls.Also they recommended switching off the bed during robotic cases to prevent unintended movement.

• Brand Name: SURGICAL BED HAND CONTROL
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): SKYTRON, LLC; 5085 corporate exchange blvd se; grand rapids MI 49512
• MDR Report Key: 9409491
• MDR Text Key: 169058365
• Report Number: 9409491
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3600 SERIES
• 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: 12/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 31755 DA