FDA Adverse Event
Malfunction
Summary report: N
ARTICULATOR, ESOPHAGUS RETRACTOR, ROTO-LO
MDR report key: 857533
·
Received May 17, 2007
Report
- Report Number
- 2430952-2007-00014
- Event Type
- Malfunction
- Date Received
- May 17, 2007
- Report Date
- May 16, 2007
- Manufacturer
- KOSCHER & WUERTZ GMBH
- Product Code
- GAD
- Product Problem
- Yes
- Report Source
- Distributor report
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THE USER FACILITY REPORTED DURING A PROCEDURE, THE PIN CAME OUT OF THE RETRACTOR. THE PIN WAS RETRIEVED FROM THE PT AND SUBMITTED WITH THE INSTRUMENT FOR EVAL. THE INSTRUMENT WAS IN USED FROM 2/7/07 TO 3/8/07. NO PT INJURY IS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTICULATOR, ESOPHAGUS RETRACTOR, ROTO-LO | ENDOSCOPIC INSTRUMENT | GAD | KOSCHER & WUERTZ GMBH | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |