FDA Adverse Event
Other
Summary report: N
*
MDR report key: 967115
·
Received June 12, 2006
Report
- Report Number
- 8010877-2006-00003
- Event Type
- Other
- Date Received
- June 12, 2006
- Manufacturer
- KOSCHER & WUERTZ GMBH
- Product Code
- ---
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
THE EXACT CAUSE OF THE DEFECTS CANNOT BE CONCLUSIVELY DETERMINED. PROBABLE REASONS COULD BE: -THE AGE OF THE INSTRUMENT, -STERILIZING THE INSTRTMENT REPEATEDLY WHILE AN INSERT WAS ATTACHED TO THE HANDLE, -USING IMPROPER CHEMICALS FOR CLEANING AND STERILIZATION, -TOO HIGH TEMPERATURES DURING CLEANING AND STERILIZATION, -IMPAIRMENTS BY DROPPING THE INSTRUMENT OR ANY IMPACTS DURING USAGE, CLEANING AND STERILIZATION. BASED ON OUR DETAILED EVAL WE CAN EXCLUDE THAT A MATERIAL DEFECT, A DEFECT IN DESIGN OR A DEFECT IN MANUFACTURING CAUSED OR CONTRIBUTED TO THIS INCIDENT. THUS, WE FEEL THAT NO CORRECTIVE HAS TO BE TAKEN ON OUR PART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | * | --- | KOSCHER & WUERTZ GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |