NUBLUE TRENDELENBURG POSITIONING KIT
Received May 27, 2026 · Event occurred May 15, 2026
Report 25300585 · MDR key 25300585
Device
Patient
74 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PATIENT IS POSITIONED IN TRENDELENBURG FOR A DA VINCI HYSTERECTOMY. WHEN POSITIONING HER AT THE START OF THE CASE CIRCULATOR AND SURGEON. PATIENT IS LAYING ON TRENDELENBURG POSITIONING KIT BY SOULE MEDICAL (NO LOT OR SERIAL NUMBER LISTENED ON PACKAGING) ALL THE PROVIDED POSITIONING WAS USED TO SECURE THE PATIENT TO THE SURGICAL TABLE, DR. WAS ASKED IF SHE WANTED TO USE THE TRENGARD POSITIONING SYSTEM, SHE STATED SHE DIDN'T USE IT, SO IT WASN'T UTILIZED. THE SURGEON HAD PLACED THE TROCARS AND PLACED THE PATIENT IN TRENDELENBURG FOR THE FIRST TIME AND STARTED TO REMOVED ADHERED TISSUE TO PLACE THE FINAL TROCAR BEFORE WE MOVED THE ROBOT TO THE BED. WHILE THE CIRCULATOR WAS MOVING THE ROBOT IN ASKING IF SHE THOUGHT THE PATIENT HAD SLIDE TOWARD THE HEAD, HER LEGS FELT STRAIGHTER THEN WHEN WE ORIGINALLY DRAPED. BETWEEN DR, CRNA [CERTIFIED REGISTERED NURSE ANESTHETIST] AND CIRCULATOR IT WAS DECIDED THAT THE PATIENT HAD SLIDE TOWARD THE HEAD. CRNA USED A MARKER TO MARK THE PATIENT'S POSITION AT THE TIME WE NOTICED SHE SLIDE TO MONITOR AS WE CONTINUED THE CASE. PATIENT'S BMI OF 22 CAUSED THE SURGEON TO QUESTION THE POSITIONING DEVICE.