MANUAL SCREWDRIVER (MEDIUM) STST 0.9
Received Feb 16, 2023 · Event occurred Sep 13, 2022
Report 3008261720-2022-14828 · MDR key 16384278
Device
Product problems
- Improper or Incorrect Procedure or Method
- Improper or Incorrect Procedure or Method
Patient
Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING THE SURGERY THE DENTIST DID NOT FOLLOW THE IFU INSTRUCTION: "BEFORE USING THIS PRODUCT, IT IS RECOMMENDED TO TIE A SAFETY THREAD IN THE HOLE TO AVOID ANY MOVEMENT OR THE RISK OF IT BEING SWALLOWED OR INHALED BY THE PATIENT." THIS WAY, THE SCREWDRIVER HAS DISLOCATED AND WAS SWALLOWED BY THE PATIENT. THE PATIENT WAS SUBMITTED TO A COLONOSCOPY TO REMOVE THE SCREWDRIVER OF THEIR INTESTINE. THE PATIENT DID NOT PRESENT ANY SYMPTOM AND IS DOING WELL AND STABLE, THERE ARE NO FURTHERS INFORMATION ABOUT THE CASE. THE EVENT DID NOT BROUGHT DAMAGES TO THE PATIENT¿S HEALTH, BUT IF RECURS THERE IS POTENTIAL TO CAUSE INJURIES.