FDA Adverse Event Injury Summary report: N

SKYTRON, SPLIT LEG EXTENSION

MDR report key: 6057010 · Received October 24, 2016

Report

Report Number
MW5065619
Event Type
Injury
Date Received
October 24, 2016
Date of Event
October 11, 2016
Report Date
October 24, 2016
Manufacturer
SKYTRON
Product Code
JEA
Report Source
Voluntary report
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

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.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
702463 SKYTRON, SPLIT LEG EXTENSION SPLIT LEG EXTENSION JEA SKYTRON

Patients

Seq Age Sex Outcome Treatment
1 67 YR Required Intervention