MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-03-22 for * manufactured by Karl Storz Imaging, Inc..
[8026968]
Svc eval confirmed that middle button had come off the camera head; this is a material issue that the mfr is addressing with the supplier.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2027009-2008-00007 |
| MDR Report Key | 1027743 |
| Report Source | 06 |
| Date Received | 2008-03-22 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2008-04-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 175B CREMONA DR. |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal | 93117 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | * |
| Product Code | FWG |
| Date Received | 2008-03-22 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 994311 |
| Manufacturer | KARL STORZ IMAGING, INC. |
| Manufacturer Address | 175 CREMONA DR. GOLETA CA 93117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-03-22 |