inforMED
InjuryFJL

INNER SHEATH FOR 27050 SC

Received Jul 7, 2026 · Event occurred Jun 21, 2026

Report 9610617-2026-01565 · MDR key 25740804

Device

Generic name

Inner Sheath For 27050 Sc

Model number

27050CA

Catalog number

27050CA

Lot number

UT04

Product problems

  • Break

Patient

NA · Unknown

  • Foreign Body In Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT "NOT LONG AFTER INSERTING RESECTOSCOPE SHEATH THE CONSULTANT NOTICED FOREIGN OBJECT FLOATING IN THE BLADDER. REALISED IT WAS PART OF THE SHEATH'S CERAMIC BEAK. THE CONSULTANT WAS UNABLE TO RETRIEVE THE PIECE. THE PATIENT HAD A VERY LARGE PROSTATE, AS SUCH IT WAS DIFFICULT TO EVEN MANIPULATE THE SCOPE ENOUGH TO ADEQUATELY VISUALISE IT. PATIENT CURRENTLY HAS A CATHETER IN. BEAK RETAINED IN BLADDER. CATHETER REQUIRED, WITH FURTHER PROCEDURE REQUIRED IN FUTURE."

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).