inforMED
MalfunctionOCZ

MONOPOLAR SCISSORS

Received Nov 17, 2022 · Event occurred Oct 25, 2022

Report 15814044 · MDR key 15814044

Device

Generic name

Endoscopic Grasping/cutting Instrument, Non-powered

Model number

0250181164

Catalog number

0250-181-164

Lot number

2040218

Product problems

  • Defective Device

Patient

Unknown

  • Partial thickness (Second Degree) Burn
  • Partial thickness (Second Degree) Burn

Narrative

Description of Event or Problem

THERMAL INJURY TO PATIENT ABDOMINAL WALL DUE TO INSTRUMENT MALFUNCTION/DEFECT. THE LAPAROSCOPIC MONOPOLAR SCISSORS THAT ARE IN THE DAVINCI MULTI-PORT SET CAUSE SEVERAL THERMAL BURNS 1-2 INCHES BACK FROM THE TIPS WHEN BEING USED ON ENERGY.