inforMED
MalfunctionFBO

CYSTOSCOPE, 15FR X 370MM, ADULT,

Received Mar 7, 2025 · Event occurred Feb 19, 2025

Report 1221826-2025-00402 · MDR key 21551923

Device

Generic name

Cystoscope, 15fr X 370mm, Adult,

Model number

11272CK2

Catalog number

11272CK2

Product problems

  • Mechanical Problem
  • Mechanical Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

THE FOLLOWING DAMAGE WAS FOUND, CRACKS IN DYMAX ON ANGLE COVER, NO LEAK. PINCHED MASTER SHEATHING IN SHAFT 364MM FROM DISTAL TIP. BROKEN TAB ON VERTEBRAE 43MM FROM DISTAL TIP. DEFLECTION FAILS AT 180° UP/115° DOWN. BROKEN IMAGE FIBERS >10. DEBRIS ON D/U CAP ON HANDLE HOUSING. DEBRIS ON FOCUS RING AND DEBRIS IN WORKING CHANNEL. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THE DEVICE WILL BE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UNSOLICITED. THIS EVENT IS FILED UNDER INTERNAL COMPLAINT ID (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT TIP GOT STUCK ON SHEATH, BROKEN TIP. NO NEGATIVE IMPACT TO THE PATIENT OR USER.