MalfunctionGDY
VISTEC
Received Jun 16, 2026
Report 1423537-2026-00190 · MDR key 25525833
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7318Catalog number
7318
Product problems
- Component Missing
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT WHILE PERFORMING FINAL COUNT, ONE OF THEIR NEURO NURSES NOTICED THAT ONE OF THE ROPS DIDN'T HAVE A RADIOPAQUE STRIP.