FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM
Received May 6, 2022 · Event occurred Feb 20, 2018
Report 1221826-2022-00064 · MDR key 14307072
Device
Generic name
Flexible Cystoscope
Manufacturer
Karl Storz EndovisionModel number
11272CUK1Catalog number
11272CUK1
Product problems
- Device Contamination with Chemical or Other Material
- Device Contamination with Chemical or Other Material
Patient
Female
- Skin Inflammation/ Irritation
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
PRODUCT EVALUATION CONFIRMED THAT THE OCULAR HAS A STAIN. THE IFU HAS STATEMENTS REGARDING INSPECTION, CHECKS OF THE OBJECTIVE LENS AND EYEPIECE AND WATER QUALITY RECOMMENDATIONS. ROOT CAUSE OF THE WHITE FILM ON THE EYEPIECE IS USER ERROR - IMPROPER CLEANING AND USE OF STERILIZATION EQUIPMENT.
Description of Event or Problem
PER THE CUSTOMER: A WHITE RESIDUE AROUND THE EYEPIECE IS CAUSING ISSUES WITH THE PHYSICIAN'S EYES. ON (B)(6) 2018, THE PHYSICIAN HAD EXPERIENCED IRRITATION AND SWELLING IN HER EYELIDS AFTER USING THIS SCOPE IN CASES. THE PHYSICIAN SOUGHT MEDICAL ATTENTION AND IS USING A CREAM ON HER EYELIDS. THE PHYSICIAN IS DOING FINE. THEY FORGOT TO RINSE THE EYEPIECE, AND ISSUE OCCURRED ON (B)(6) 2018 AS WELL WITH THE SAME DOCTOR AND WITH USE OF THIS SAME SCOPE. PHYSICIAN INDICATED THAT WHEN THEY RINSED THE EYEPIECE OFF, THERE WERE NO ISSUES WITH THE SCOPE. THE HOSPITAL SPD REPROCESSES THEIR FLEXIBLE SCOPES USING STERRAD. THIS REPORT IS FOR THE FIRST CASE ON (B)(6) 2018.