MAUDE Adverse Event Report: SKYTRON SKYTRON, SPLIT LEG EXTENSION

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/11/2016

Event Type  Injury  

Event Description

A (b)(6) male admitted on (b)(6) 2016 for laparoscopic esophagectomy with celiac lymph node dissection.The split leg table broke at the right leg connection causing right leg to shift - this occurred at the initiation of procedure.The patient's leg had been secured with safety strap to the leg of the table.The surgeon and operating room staff immediately secured the patient's right leg and were able to drape the leg and remove safety strap.Surgeon assessed patient for any deficits - no apparent deficits noted.The patient's laparoscopic incisions were closed with staples and all surgical devices and drapes removed.Tables were changed out and patient re-prepped and draped for procedure to reconvene.The split leg attachment broke at the right leg connection causing right leg to shift - this occurred at the preparation stage of procedure.The bed was in reverse trendelenberg and the leg extension support broke when operating room table was put back to level.The table was purchased prior to the split leg extensions.It is clear how to apply the split legs to the table however when split legs are used in the reverse trendelenberg position the bed should be placed in level position by pressing "trendelenberg" button and not "level" button.This process was not clear or communicated to the staff.No injury to patient.

• Brand Name: SKYTRON, SPLIT LEG EXTENSION
• Type of Device: SPLIT LEG EXTENSION
• Manufacturer (Section D): SKYTRON; gran rapids MI
• MDR Report Key: 6057010
• MDR Text Key: 58498014
• Report Number: MW5065619
• Device Sequence Number: 1
• Product Code: JEA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 109