MalfunctionGDF
OMNICLOSE TROCAR SITE CLOSURE DEVICE
Received Jan 11, 2021 · Event occurred Dec 23, 2020
Report 11146572 · MDR key 11146572
Device
Generic name
Guide, Needle, Surgical
Manufacturer
Unimax Medical Systems Inc.Model number
FCL200000Lot number
6101910118
Product problems
- Break
Patient
16790 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
METAL TIP BROKE OFF IN THE PATIENT WHILE SURGEON USING. MANUFACTURER RESPONSE FOR TROCAR, (BRAND NOT PROVIDED) (PER SITE REPORTER). THEY WILL PICK IT UP TOMORROW AND REIMBURSE US WITH REPLACEMENT PRODUCT.