inforMED
MalfunctionLKF

COOPER SURGICAL - RUMI

Received Jul 15, 2021 · Event occurred Jun 25, 2021

Report 12173236 · MDR key 12173236

Device

Generic name

Cannula, Manipulator/injector, Uterine

Model number

RUMI II

Catalog number

UMH650

Product problems

  • Break

Patient

17520 DA

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE RUMI HANDLE BROKE WHILE BEING USED TO MANIPULATE A 17-WEEK UTERUS. THE HANDLE, A BENT PIN AND THE TIP THAT ARTICULATES RECOVERED. NO HARM TO PATIENT. THE SURGEON STATES THAT HE WAS AT THE CONSOLE, AND ASSISTANT AND ONE OF THE NEW INTERNS WERE TAKING TURNS MANIPULATING THE UTERUS, SO THEY'LL BETTER BE ABLE TO ANSWER THE SPECIFIC QUESTIONS ABOUT THE MANEUVERS. THEY WERE USING THE INSTRUMENT IN THE STANDARD WAY, AND WE ARE NOT SURE WHAT MOMENT THAT IT BROKE, JUST THAT IT WASN¿T RESPONDING IN THE USUAL WAY. INITIALLY WE THOUGHT THE INTERN WAS JUST STRUGGLING TO LEARN THE TECHNIQUE, BUT WHEN ASSISTANT ALSO COULDN¿T MAKE IT WORK, SHE DISCOVERED BY FEEL -AND THEN VISUALLY, WHEN SHE REMOVED IT - THAT IT WAS BROKEN. THERE WAS NO INJURY TO THE PATIENT, BUT THERE WAS POTENTIAL FOR INJURY, AS A SHARP PIN/PIECE OF METAL BROKE OFF. THE BROKEN PIECE WAS IN THE VAGINA AND WAS RETRIEVED.