KARL STORZ
Received Nov 22, 2010 · Event occurred Oct 22, 2010
Report 9610617-2010-00038 · MDR key 1912728
Device
Generic name
Frontal Ostium Seeker
Manufacturer
Karl Storz Gmbh & Co. KgModel number
629825Catalog number
629825
Lot number
UNK
Product problems
- Break
Patient
Not reported
- Device Embedded In Tissue or Plaque
Narrative
Additional Manufacturer Narrative
THIS PRODUCT WAS DISCONTINUED IN 2004. WE HAVE NO OTHER COMPLAINTS IN OUR SYSTEM ON THIS DEVICE.
Description of Event or Problem
ALLEGEDLY, THE DOCTOR WAS PERFORMING A BILATERAL SINUS SURGERY WHEN A SMALL METAL BALL AT ONE END OF THE DEVICE BROKE OFF AND BECAME STUCK IN PATIENT. THEY X-RAYED PATIENT AND CONFIRMED 1 MM BALL WAS PRESENT. THEY TRIED MAGNETS TO REMOVE IT, BUT WERE UNSUCCESSFUL. AFTER MINOR DELAY, DOCTOR COMPLETED PROCEDURE. AT THE TIME OF THE EVENT, THE DOCTOR STATED THAT HE WAS NOT RESCHEDULING TO RETRIEVE PIECE; HE SAID IT WAS EQUIVALENT TO LEAVING A HEMACLIP IN PATIENT. HE STATED HE DOES NOT BELIEVE IT POSES ANY RISK OF INJURY TO THE PATIENT.