MalfunctionGCP
CYSTOSCOPE SHEATH, 21FR.
Received Jun 30, 2026 · Event occurred Jun 8, 2026
Report 9610773-2026-04679 · MDR key 25667097
Device
Product problems
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS ONGOING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Description of Event or Problem
IT WAS REPORTED THE CYSTOSCOPE SHEATH STOPCOCK CAME OFF DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.