MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-12-20 for KARL STORZ 495NCS manufactured by Karl Storz Endovision.
Report Number | 2020550-2007-00034 |
MDR Report Key | 980508 |
Date Received | 2007-12-20 |
Date of Report | 2007-12-18 |
Date of Event | 2007-11-14 |
Date Facility Aware | 2007-11-19 |
Report Date | 2007-12-18 |
Date Reported to FDA | 2007-12-18 |
Date Reported to Mfgr | 2007-12-18 |
Date Added to Maude | 2008-01-17 |
Event Key | 0 |
Report Source Code | Distributor report |
Manufacturer Link | N |
Number of Patients in Event | 0 |
Adverse Event Flag | 3 |
Product Problem Flag | 3 |
Reprocessed and Reused Flag | 3 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 3 |
Single Use | 0 |
Previous Use Code | 0 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | KARL STORZ |
Generic Name | LIGHT CABLE |
Product Code | FFZ |
Date Received | 2007-12-20 |
Model Number | 495NCS |
Catalog Number | 495NCS |
Lot Number | UNK |
ID Number | * |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | UNKNOWN |
Implant Flag | N |
Date Removed | * |
Device Sequence No | 1 |
Device Event Key | 948207 |
Manufacturer | KARL STORZ ENDOVISION |
Manufacturer Address | * CHARLTON MA * US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 2007-12-20 |