MalfunctionFBO
TUBE, INNER ROTATABLE CERAMIC
Received May 8, 2020 · Event occurred Apr 8, 2020
Report 9610617-2020-00063 · MDR key 10040439
Device
Generic name
Urology Sheath
Manufacturer
Karl Storz Se & Co. KgModel number
27050XBCatalog number
27050XB
Lot number
AA
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
Not reported
- Foreign Body In Patient
- Foreign Body In Patient
Narrative
Additional Manufacturer Narrative
CUSTOMER WILL NOT RETURN THE DEVICE FOR EVALUATION. WE LEARNED FROM OUR FIELD SERVICE THAT THEY USE 3RD PARTY REPAIRS TO SUPPORT THIS PRODUCT.
Description of Event or Problem
ALLEGEDLY, DURING A UROLOGIC STENT INSERTION, CERAMIC TIP BROKE OFF IN PATIENT; THE SURGEON IRRIGATED THE BLADDER AND REMOVED A 2MM PIECE AND SUSPECT IT IS MISSING ANOTHER SMALL PIECE BUT DID NOT SEE ANYTHING ELSE. NO HARM TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER SURGICAL INTERVENTION.