InjuryGBL
CALCULASE III FIBER 230 ¿M REUSABLE
Received Feb 26, 2024 · Event occurred Feb 12, 2024
Report 2020550-2024-00047 · MDR key 18778948
Device
Generic name
Calculase Iii Fiber 230 ¿m Reusable
Manufacturer
Karl Storz Se & Co. KgModel number
UL007Catalog number
UL007
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. DEVICE WAS NOT RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT A FRAGMENT OF FIBER BROKE OFF IN PATIENT DURING PROCEDURE AFTER SECOND USE OF FIBER.