MID LABS
Received May 11, 2012 · Event occurred Apr 12, 2012
Report 2935428-2012-00001 · MDR key 2584885
Device
Generic name
Vitreous Cutter
Catalog number
2540CE
Lot number
11070508
Product problems
- Failure to Cut
Patient
UNK
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
DR. TRIED TWO CUTTERS OF 2540CE BOTH IN THE SAME LOT AND THEY WOULD NOT CUT. THEY DIDN'T DO ANYTHING. THEY DID HAVE PT CONTACT, BUT NO INJURY. CUTTERS WERE TESTED PRIOR TO SURGERY AND WORKED. WHEN SURGERY STARTED THE CUTTER SOUNDED LIKE IT WAS WORKING BUT WAS NOT CUTTING. ASPIRATION CONTINUED. THEY TRIED THE 20 GAUGE THEY HAD ON HAND AND IT WORKED. THEY BORROWED A 25 GAUGE FROM THE HOSP WITH A DIFFERENT LOT NUMBER AND THEY ALSO WORKED.
Additional Manufacturer Narrative
DEVICE EVAL SUMMARY: REPORT: VITREOUS CUTTER DID NOT CUT. ANALYSIS: VITREOUS CUTTER TESTED AND INSPECTED AND FOUND TO MEET SPECIFICATION.