FDA Adverse Event
Other
Summary report: N
9610617-2008-00032
MDR report key: 1321108
·
Received January 2, 2009
Report
- Report Number
- 9610617-2008-00032
- Event Type
- Other
- Date Received
- January 2, 2009
- Product Code
- KOG
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
EVAL STATED THAT DAMAGE (HOLES IN BLOCK, INCORRECT MATERIAL, EPOXY CONNECTION FAILURE-RESEALED AT CONE) WAS DUE TO 3RD PARTY REPAIR AND AGE (17 YEARS OLD) OF INSTRUMENT. THE 27005B/SCOPE BECAME OBSOLETE IN DECEMBER OF 1997 AND WAS REPLACED BY THE 27005BA, AUTOCLAVABLE SCOPE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KOG |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |