MalfunctionMMP
INTRAOPERATIVE PROBE COVER WITH GEL
Received Jun 24, 2025 · Event occurred Mar 31, 2025
Report 22318182 · MDR key 22318182
Device
Generic name
Cover, Barrier, Protective
Manufacturer
Vital Care Industries, Llc.Model number
VPC0677Catalog number
VPC0677
Lot number
2409E026
Product problems
- Material Split, Cut or Torn
Patient
55 YR · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE C-TRACK PROBE COVER WAS USED TO COVER C-TRACK DEVICE FOR BREAST PROCEDURE. IT WAS NOTED PRIOR TO USE THAT IT HAD A TEAR CLOSE TO THE TIP. A NEW PROBE COVER WAS OPENED AND THE MD CONTINUED WITH THE CASE. NO DELAY. MD STATED THAT THIS WAS THE FOURTH TIME SHE HAS NOTED A PROBE COVER DEVELOPING A TEAR. NO HARM TO PATIENT.