FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 1912728
·
Received November 22, 2010
Report
- Report Number
- 9610617-2010-00038
- Event Type
- Other
- Date Received
- November 22, 2010
- Date of Event
- October 22, 2010
- Report Date
- November 22, 2010
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- FGM
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS PRODUCT WAS DISCONTINUED IN 2004. WE HAVE NO OTHER COMPLAINTS IN OUR SYSTEM ON THIS DEVICE.
Description of Event or Problem · 1
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | FRONTAL OSTIUM SEEKER | FGM | KARL STORZ GMBH & CO. KG | 629825 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |