MIDLABS VITROUS CUTTER
Received Aug 28, 2015 · Event occurred Feb 16, 2012
Report 2935428-2015-00003 · MDR key 5045302
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 ACCURUS 400 SYSTEM AND IT DID NOT CUT AND NO WATER ENTERED. THE OBSERVATION WAS MADE PRIOR TO USE ON THE PATIENT. THE DEVICE DESCRIPTION IS A 20G, R4, VC (P/N (B)(4) INTO 2900CE, LOT #13041508). THE PATIENT WAS UNDERGOING SURGERY, BUT THE DEVICE DID NOT MAKE DIRECT CONTACT WITH THE PATIENT AND THERE WAS NO REPORTED PATIENT INJURY AND SURGERY WAS COMPLETED. THE INCIDENT WAS REPORTED TO MID LABS ON (B)(6) 2015. THE DEVICE WAS RETURNED TO MID LABS AND RECEIVED ON (B)(6) 2015.