inforMED
MalfunctionNBG

ENDOINK

Received Jul 13, 2022 · Event occurred Apr 9, 2022

Report 14999540 · MDR key 14999540

Device

Generic name

Endoscopic Marker

Catalog number

ENK10

Lot number

M210719252

Product problems

  • Leak/Splash

Patient

9855 DA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

THE LUER TIP OF THE ENDOINKTM ENDOSCOPIC MARKER LEAKED WHEN ATTACHED TO SYRINGE. A NEW SETUP WAS OBTAINED AND CASE CONTINUED WITHOUT INCIDENT. THE ORIGINAL DEVICE AND PACKAGING WERE DISCARDED AFTER NUMBERS ATTACHED, EDUCATION PROVIDED TO SAVE ITEMS EVEN IF MESSY.