inforMED
MalfunctionFCZ

ULTRA PLUME AWAY 6.0

Received Dec 18, 2018 · Event occurred Dec 17, 2018

Report MW5082278 · MDR key 8180620

Device

Generic name

Laparoscopic Smoke Evacuator

Model number

0620-030-606

Catalog number

0620-030-606

Lot number

256710

Product problems

  • Material Twisted/Bent

Patient

37 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

COOPER SURGICAL INC., ULTRA PLUME AWAY 6.0 WAS RECEIVED IN THE STERILE PACKAGING WITH THE SUCTION TUBING BENT OVER THE TUBING CONNECTOR TO THE POINT WHERE THE MEMORY OF THE TUBING COULD NOT BE CORRECTED, AND THE DEVICE COULD NOT BE UTILIZED.