MalfunctionCAL
FIVE S 3.5X65, STERILE, FOR SINGLE USE,
Received Mar 11, 2026 · Event occurred Feb 1, 2026
Report 9610617-2026-00527 · MDR key 24569347
Device
Generic name
Five S 3.5x65, Sterile, For Single Use,
Manufacturer
Karl Storz Se & Co.kgModel number
091361-06Catalog number
091361-06
Lot number
500124286
Product problems
- Material Separation
Patient
67 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WILL NOT BE FORWARDED TO THE MANUFACTURER FOR FURTHER 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: CCOPE HAD SHAFT SEPARATION DURING PROCEDURE AND DISTAL TIP. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.