FDA Adverse Event
Other
Summary report: N
KARL STORZ
MDR report key: 1586268
·
Received January 9, 2010
Report
- Report Number
- 9610617-2010-00001
- Event Type
- Other
- Date Received
- January 9, 2010
- Date of Event
- December 9, 2009
- Report Date
- January 8, 2010
- Manufacturer
- KARL STORZ GMBH & CO. KG
- Product Code
- EOX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FIRST USE. DEVICES WERE DISPOSED OF AFTER THE CASE.
Description of Event or Problem · 1
ALLEGEDLY, DURING A SIALENDOSCOPY PROCEDURE, THE DOCTOR ENCOUNTERED SEVERE STENOSIS; TWO 4-WIRE 11582MS BROKE; ANOTHER 6-WIRE BASKET WAS TRIED BUT DOCTOR WAS UNABLE TO GET PAST STENOSIS. HE SWITCHED TO AN OPEN PROCEDURE TO REMOVE STONES; THIS ADDED ABOUT AN HOUR TO THE PROCEDURE. DOCTOR FELT ANATOMICAL DIFFICULTIES WERE THE CAUSE RATHER THAN FAILURE OF THE INSTRUMENT. POSSIBLE PT WAS NOT A GOOD CANDIDATE FOR ENDOSCOPY DUE TO SIZE AND PLACEMENT OF STONES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KARL STORZ | ESOPHAGOSCOPE | EOX | KARL STORZ GMBH & CO. KG | 11582M | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |