MalfunctionEKD
JACOBSON MICRO MOSQ 5 CV
Received Dec 24, 2014
Report 2523190-2014-00073 · MDR key 4380111
Device
Product problems
- Break
- Detachment Of Device Component
Patient
32 YR
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER INITIALLY REPORTS THE TIP BROKE IN PT ON FIRST USE FROM PACKAGE. ON (B)(6) 2014 CUSTOMER REPORTS DOCTOR WAS PERFORMING A THYROIDECTOMY WHEN HE MANIPULATED THE TIP OF THE DEVICE UNDER A BLOOD VESSEL AND IT BROKE OFF. TIP EASILY RETRIEVED, NO HARM DONE. DOCTOR FELT NO NEED FOR X-RAY.
Additional Manufacturer Narrative
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.