inforMED
InjuryFBO

INNER SHEATH, FOR 27040 SM

Received Jul 5, 2023 · Event occurred Jun 23, 2021

Report 9610617-2023-00646 · MDR key 17261038

Device

Generic name

Endoscope Sheath, Reusable

Model number

27040XB

Catalog number

27040XB

Lot number

YW01

Product problems

  • Detachment of Device or Device Component
  • Detachment of Device or Device Component

Patient

Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS EVENT WITH A "INNER SHEATH". ACCORDING TO THE INFORMATION RECEIVED, THE BEAK TIP IS BROKEN OFF IN THE PATIENT. UNSURE, IF THE BROKEN PIECE RETRIEVED. FURTHER INFORMATION IS NOT AVAILABLE.

Additional Manufacturer Narrative

BELATED EVALUATION AND REPORTING OF THIS COMPLAINT WAS DONE DURING RETROSPECTIVE REVIEW AS PART OF CAPA 22-0074 CORRECTIVE ACTION 6. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID (B)(4). UPON THE EVALUATION IT COULD BE CONFIRMED THAT THE PART OF THE CERAMIC BEAK IS BROKEN. IN ADDITION, THE METAL SHAFT HAS TWO DENTS ABOUT 50 MM BEHIND THE DISTAL END, THIS COULD POTENTIAL BE DUE TO HIGH MECHANICAL FORCE APPLIED. FURTHERMORE, THERE IS A BURN MARK ON THE INSIDE OF THE CERAMIC BEAK. THE ROOT CAUSE OF THE BREAKAGE IS MOST LIKELY DUE TO MECHANICAL OVERLOAD CAUSING DEVICE TO BREAK. THE DAMAGE OF THE PRODUCT IS NOT CAUSED BY A PRODUCTION PROBLEM OR MATERIAL DEFECT.