MalfunctionHQE
MIDLABS
Received Aug 28, 2015 · Event occurred Jun 27, 2014
Report 2935428-2015-00004 · MDR key 5045303
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
UNK
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
PROBE PASSED ALL MID PRODUCTION TESTING AND IS FULLY FUNCTIONAL.
Description of Event or Problem
PHYSICIAN ATTEMPTED TO USE CUTTER WITH AN ALCON SYSTEM AND IT DID NOT CUT. THE DEVICE DESCRIPTION IS A 23G, RI, VC ((B)(4)). THE PATIENT WAS UNDERGOING SURGERY, BUT THE DEVICE DID NOT MAKE DIRECT CONTACT WITH THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY. THE INCIDENT WAS REPORTED TO MID LABS ON (B)(6) 2015. THE DEVICE WAS RETURNED TO MID LABS AND RECEIVED ON (B)(6) 2015.