MalfunctionFEO
LITHOCLAST
Received Mar 30, 2022 · Event occurred Mar 15, 2022
Report 13948873 · MDR key 13948873
Device
Generic name
Lithotriptor, Ultrasonic
Manufacturer
E.m.s. Electro Medical Systems S.a.Model number
FR-284Catalog number
M0068402940
Lot number
182171A
Product problems
- Break
Patient
28470 DA · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING PROCEDURE, ITEM BROKE INTO TWO PIECES.