MalfunctionNAY

DAVINCI HARMONIC

Received Feb 12, 2026 · Event occurred Feb 6, 2026

Report MW5183726 · MDR key 24322805

Device

Generic name

System, Surgical, Computer Controlled Instrument

Manufacturer

Intuitive Surgical, S. De R.l. De C.v.

Model number

480275

Lot number

K10250925

Patient

46 YR · Female

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DAVINCI HARMONIC IN USE AND BROKE, NO PATIENT HARM, BOTH PIECES REMOVED FROM PATIENT. NEW HARMONIC USED TO FINISH CASE. HARMONIC THAT BROKE REF NUMBER 480275, LOT K10250925, EXP 2028/09/30, VER 12.