inforMED
MalfunctionGDY

VISTEC

Received Aug 7, 2025 · Event occurred Jul 18, 2024

Report 1423537-2025-00315 · MDR key 22745545

Device

Generic name

Gauze/sponge, Internal, X-ray Detectable

Model number

7317

Catalog number

7317

Lot number

23K051262

Product problems

  • Component Missing
  • Component Missing

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • 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 ONLY 9 IN THE TRAY INSTEAD OF 10.

Additional Manufacturer Narrative

THE SAMPLES OR THE PICTURES OF THE PRODUCT WERE NOT AVAILABLE FOR EVALUATION AND THE COMPLAINT COULD NOT BE CONFIRMED AT THIS TIME SINCE THE SAMPLE AND THE PICTURES THAT WERE SUPPLIED BY THE CUSTOMER ONLY SHOW THE TRAY COVER AND NOT THE MISCOUNTED PRODUCT. SAMPLES/PICTURES OF THE MISCOUNTED PRODUCT ARE REQUIRED TO PERFORM VISUAL EVALUATIONS TO VERIFY THE COMPLAINT. COMPLAINT INVESTIGATIONS WILL BE UPDATED BASED ON SAMPLE¿S AVAILABILITY.