SC+ QBL SOFTWARE
Received Dec 3, 2024 · Event occurred Nov 19, 2024
Report 3015967359-2024-02376 · MDR key 20837736
Device
Generic name
Counter, Sponge, Surgical
Manufacturer
Stryker Instruments-a Division Of Stryker CorpCatalog number
0894-000-005
Product problems
- High Readings
- High Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: ADDITIONAL INFORMATION IS NOT AVAILABLE TO COMPLETE THE GTIN, THE SERIAL NUMBER IS UNKNOWN.
Description of Event or Problem
DURING A PROCEDURE, THE CUSTOMER COUNTED OUT FIVE 4X18-LAP SPONGES. USING THE AUTOMATED SPONGE WEIGHING TAB, THE CUSTOMER PLACED THE FIVE LAPS INTO THE BUCKET AND TAPPED ¿ANALYZE.¿ THE USER RECEIVED A MESSAGE SAYING THAT THE DRY WEIGHT EXCEEDED THE WET WEIGHT, EVEN THOUGH SEVERAL OF THE LAPS WERE SOAKED IN BLOOD. THE AUTOMATED SPONGE COUNT/WEIGHT PORTION DOUBLED THE DRY WEIGHT OF THE SPONGES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Description of Event or Problem
DURING A PROCEDURE, THE CUSTOMER COUNTED OUT FIVE 4X18-LAP SPONGES. USING THE AUTOMATED SPONGE WEIGHING TAB, THE CUSTOMER PLACED THE FIVE LAPS INTO THE BUCKET AND TAPPED ¿ANALYZE.¿ THE USER RECEIVED A MESSAGE SAYING THAT THE DRY WEIGHT EXCEEDED THE WET WEIGHT, EVEN THOUGH SEVERAL OF THE LAPS WERE SOAKED IN BLOOD. THE AUTOMATED SPONGE COUNT/WEIGHT PORTION DOUBLED THE DRY WEIGHT OF THE SPONGES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME DEVICE WITHOUT A SURGICAL DELAY; NO MEDICAL INTERVENTION OR ADVERSE CONSEQUENCES WERE REPORTED.
Additional Manufacturer Narrative
CORRECTED DATA: UPON FURTHER INVESTIGATION, THE SPECIFIC CAUSE OF THE INACCURATE MEASUREMENT WILL NOT RESULT IN HARM GREATER THAN SEVERITY 0 (USER ANNOYANCE), AND THEREFORE IT IS NOT LIKELY THAT A REOCCURRENCE OF THIS EVENT WILL LEAD TO A SERIOUS INJURY OR DEATH.