inforMED
MalfunctionODB

CATHETER DEFLECTING MECHANISM

Received Mar 13, 2026 · Event occurred Feb 27, 2026

Report 9610617-2026-00559 · MDR key 24592372

Device

Generic name

Catheter Deflecting Mechanism

Model number

27067EF

Catalog number

27067EF

Lot number

RU06

Product problems

  • Material Separation

Patient

NA · Unknown

  • Insufficient Information

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE END OF THE DEFLECTING MECHANISM HAD BEEN BROKEN AND WAS FOUND TO BE MISSING. THE CUSTOMER WAS INFORMED OF THIS AND IS TRYING TO PROVIDE FURTHER INFORMATION ON THE WHEREABOUTS OF THE MISSING PART. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).

Additional Manufacturer Narrative

THIS SUPPLEMENTAL REPORT IS TO CORRECT SECTION B3 EVENT DATE. THE EVENT DATE IS UNK FOR THIS CASE. THE DEVICE IN QUESTION WAS RETURNED TO THE MANUFACTURER. THE EVALUATION IS ANTICIPATED, BUT NOT YET BEGUN. THE INVESTIGATION WILL BE PERFORMED BY A DESIGNATED KARL STORZ EMPLOYEE. THE EVENT IS FILED UNDER INTERNAL KARL STORZ COMPLAINT ID: (B)(4).