MalfunctionFFY
CLEANASCOPE
Received Jun 16, 2026 · Event occurred Apr 2, 2026
Report 3012708860-2026-00001 · MDR key 25524330
Device
Generic name
Sterile Cover
Manufacturer
Steris Italy S.r.l.Model number
STERILE TRAY LINER SYSTEMCatalog number
103580
Lot number
(10)2508037602
Product problems
- Insufficient Device Problem Information
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION INTO THE REPORTED EVENT IS CURRENTLY IN PROGRESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
THE USER FACILITY REPORTED VIA VIGILANCE REPORT THAT THE STERILE TRANSPARENT ENDOSCOPE COVER TO THEIR CLEANASCOPE "TEARS AS SOON AS TENSION IS APPLIED TO IT ON THE TRAY". NO REPORT OF INJURY.