inforMED
MalfunctionCCX

NUBLUE TRENDELENBURG POSITIONING KIT

Received May 27, 2026 · Event occurred May 15, 2026

Report 25300585 · MDR key 25300585

Device

Generic name

Support, Patient Position

Manufacturer

The Soule Co

Model number

TP 3000E_S-NBDS-AP

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.