MalfunctionHBQ
WECK HEM-O-LOK
Received Dec 24, 2013 · Event occurred Aug 15, 2013
Report 3588765 · MDR key 3588765
Device
Generic name
Ligating Clip
Manufacturer
Telefex MedicalModel number
*Catalog number
544240
Lot number
01B1300444
Product problems
- Failure to Form Staple
Patient
62 YR
- No Information
Narrative
Description of Event or Problem
ENDOWRIST CLIP APPLIERS WITH WECK HEM-O-LOK CLIPS WAS BEING USED WHEN THE CLIPS WOULD CLOSE BUT NOT LOCK. MULTIPLE ATTEMPTS WERE MADE WITH DIFFERENT CLIPS FROM DIFFERENT PACKS. A TOTAL OF 5 PACKS AND DIFFERENT APPLIERS WERE USED TO RULE OUT CALIBRATION ISSUES. NO BLOOD LOSS WAS NOTED AND NO INCISION WAS MADE UNTIL THE CLIPS WORKED APPROPRIATELY.