MalfunctionGDY
VISITEC
Received Jun 12, 2026 · Event occurred Apr 8, 2026
Report 25485072 · MDR key 25485072
Device
Generic name
Gauze/sponge, Internal, X-ray Detectable
Manufacturer
Cardinal Health 200, LlcModel number
7317Lot number
24J056162
Patient
NA · Unknown
- Insufficient Information
Narrative
Description of Event or Problem
DURING THE PROCEDURE AND PACK OF RAYTECS WERE OPENED ON THE SURGICAL FIELD AND COUNTED. SCRUB PERSONNEL NOTICED THERE WAS NOT AN RFID [RADIO-FREQUENCY IDENTIFICATION] SEWN INTO THE RAYTECS. RAYTECS WERE IMMEDIATELY REMOVED FROM THE FIELD AND ACCOUNTED FOR. PACKAGING WAS RECOVERED, GIVEN AND ESCALATED TO MANAGEMENT.