inforMED
MalfunctionLWH

SURGICOUNT TABLET

Received Jul 11, 2024 · Event occurred Jun 14, 2024

Report 3015967359-2024-01254 · MDR key 19725934

Device

Generic name

Electronic Surgical Sponge-counter

Catalog number

0694-001-010

Product problems

  • False Positive Result
  • False Positive Result

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

UPDATE: D9, H3, H6 CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. UPDATE: D4 ADDITIONAL INFORMATION: GTIN.

Description of Event or Problem

PER THE ACCOUNT, THE TABLET DID NOT INDICATE A WOUND PACK WAS STILL PRESENT, WHICH COULD LEAD TO A SPONGE BEING RETAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.

Description of Event or Problem

PER THE ACCOUNT, THE TABLET DID NOT INDICATE A WOUND PACK WAS STILL PRESENT, WHICH COULD LEAD TO A SPONGE BEING RETAINED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.