ECOLAB
Received Dec 8, 2015 · Event occurred Oct 20, 2015
Report 8043817-2015-00007 · MDR key 5275298
Device
Product problems
- Leak/Splash
Patient
Not reported
- Missing Value Reason
Narrative
Additional Manufacturer Narrative
SINCE NO DEVICE WAS RETURNED FOR ANALYSIS, THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.
Description of Event or Problem
AN END USER FOUND THAT A WARMER DRAPE HAD A HOLE IN IT. AT THE END OF A SURGICAL PROCEDURE, THE STERILE DRAPE WAS TAKEN OUT OF THE SOLUTION WARMER AND LIQUID WAS NOTED IN THE SOLUTION WARMER OUT SIDE OF THE DRAPE INDICATING THERE MAY HAVE BEEN A HOLE IN THE DRAPE. PHYSICIAN WAS NOTIFIED. THE PROCEDURE THAT WAS PERFORMED TO THE PATIENT WAS ABDOMINAL HYSTERECTOMY WITH BILATERAL SALPINGO-OOPHORECTOMY AND PERITONEAL MEDIPORT PLACEMENT. THERE WERE NO PATIENT INJURY AND TREATMENT REPORTED TO THE INCIDENT.