MalfunctionFEO
LITHOCLAST
Received Oct 31, 2024 · Event occurred Aug 27, 2024
Report 20577450 · MDR key 20577450
Device
Generic name
Lithotriptor, Ultrasonic
Manufacturer
E.m.s. Electro Medical Systems S.a.Model number
FR-286Catalog number
M0068402920
Lot number
210183A
Patient
58 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
AS WE WERE USING THE PRODUCT, IT BROKE IN HALF. BOTH PIECES WERE REMOVED FROM THE FIELD.