MalfunctionGDY
SURGICOUNT SAFETY SPONGE 18X18
Received Apr 22, 2025 · Event occurred Apr 1, 2025
Report 21881408 · MDR key 21881408
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Stryker InstrumentsCatalog number
0611-018-180
Lot number
1395
Product problems
- Detachment of Device or Device Component
Patient
42 YR · Female
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
A STRING FROM THE LAPAROTOMY SPONGE DETACHED AND WAS FOUND IN THE PATIENT DURING SURGERY. THE SURGEON IDENTIFIED AND REMOVED THE PIECE OF LAPAROTOMY SPONGE. TWO PACKAGES OF LAPAROTOMY SPONGES WERE OPENED FOR THE PROCEDURE WITH THE SAME LOT NUMBERS.