CALCULASE III FIBER 600 ¿M REUSABLE
Received Nov 8, 2024 · Event occurred Oct 6, 2024
Report 2020550-2024-00442 · MDR key 20637105
Device
Generic name
Laser Lithotripsy System
Manufacturer
Karl Storz Se & Co. KgModel number
UL009Catalog number
UL009
Product problems
- Sparking
- Material Integrity Problem
- Sparking
- Material Integrity Problem
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THE AFFECTED DEVICE HAS BEEN REQUESTED FOR INVESTIGATION BY THE MANUFACTURER. THE DEVICE WAS NOT YET RETURNED FOR INVESTIGATION. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).
Description of Event or Problem
IT WAS REPORTED THAT WHEN CHANGING THE PROGRAM OF THE FIBER LASER 600 MODE VAPORIZATION, A BREAKAGE OF THE LASER FIBER WAS CAUSED. WHEN THE SURGEON USED THE LASER AGAIN, SPARKS AND EXPLOSION AT THE LEVEL OF THE RED TIP - LASER FIBER TORN OFF. THIS RESULTED IN DISCONTINUATION OF THE PROCEDURE AND CHANGE OF THE EQUIPMENT.