SURGICOUNT+ SPONGE COUNTING BAG
Received Jul 1, 2025 · Event occurred Jun 1, 2025
Report 3015967359-2025-01194 · MDR key 22372936
Device
Generic name
Counter, Sponge, Surgical
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0694-002-010
Lot number
UNKNOWN
Product problems
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
- Use of Device Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
PER THE USER FACILITY, THE CIRCULATING NURSE CLOSED THE CASE BEFORE PERFORMING HER FINAL SPONGE COUNT. SINCE IT WAS A HIP PROCEDURE, X RAY WAS CALLED INTO THE ROOM TO SCAN THE PATIENT WHEN THE SPONGE WAS FOUND. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE SPONGE. THE ADDITIONAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
UPDATE: D9, H3, H6. CORRECTION: FOLLOW-UP REPORT SUBMITTED TO DOCUMENT THE DEVICE LOG FILES AND DEVICE WERE NOT AVAILABLE FOR EVALUATION.
Description of Event or Problem
PER THE USER FACILITY, THE CIRCULATING NURSE CLOSED THE CASE BEFORE PERFORMING HER FINAL SPONGE COUNT. SINCE IT WAS A HIP PROCEDURE, X RAY WAS CALLED INTO THE ROOM TO SCAN THE PATIENT WHEN THE SPONGE WAS FOUND. AN ADDITIONAL PROCEDURE WAS PERFORMED TO REMOVE THE SPONGE. PER ADDITIONAL INFORMATION, THE DEVICE WAS NOT USED TO COUNT THE SPONGES OUT. THE USER FACILITY HAS NO FURTHER INFORMATION ON THE REPORTED EVENT. THE ADDITIONAL PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.