MalfunctionMZR
LEUKOCLIP SD CARTRIDGE 10W CTN 10
Received Oct 15, 2020 · Event occurred Sep 22, 2020
Report 8043484-2020-03219 · MDR key 10684996
Device
Generic name
Topical Aproximation System
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
66047114
Lot number
UNKNOWN
Product problems
- Mechanical Jam
- Mechanical Jam
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
THIS PRODUCT IS NOT APPROVED IN THE US. THEREFORE, UNDER THE REGULATIONS SET FORTH UNDER 21 C.F.R. §803, IT IS CONCLUDED THAT THIS IS NOT A REPORTABLE EVENT TO THE FDA.
Description of Event or Problem
IT WAS REPORTED THAT STAPLES OF THE LEUKOCLIP DON'T SLIDE DOWN CORRECTLY IN THE CARTRIDGE, SO IT CAN'T BE USED PROPERLY. IT IS UNKNOWN WHEN THIS MALFUNCTION WAS DISCOVERED, BUT A BACK-UP WAS AVAILABLE AND THE TREATMENT CONTINUED WITH A SMALL DELAY. NO PATIENT HARM WAS REPORTED.