MalfunctionHNJ
MORIA PUNCH D8.00 MM
Received Oct 8, 2019 · Event occurred May 10, 2019
Report 9165941 · MDR key 9165941
Device
Generic name
Punch, Corneo-scleral
Manufacturer
Moria Inc.Model number
D8.00 MMCatalog number
17200D800
Lot number
1190209
Product problems
- Failure to Cut
- Defective Device
Patient
22630 DA
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
AFTER SURGEON CUT THE DONOR TISSUE, IT WAS NOTED THAT TISSUE WAS NOT COMPLETELY CUT MAKING TISSUE NOT USABLE FOR SURGERY. WHILE INSPECTING THE PUNCH, A DEFECT WAS NOTED ON THE BLADE. THE SECOND STAGE OF SURGERY WAS DELAYED DUE TO NEED FOR NEW TISSUE FROM EYE BANK. THE EYE INCISION SUTURED CLOSED UNTIL NEW TISSUE ARRIVED.