MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2007-01-11 for manufactured by .
[19435265]
Light cable was in good working order during and after procedure. Hospital stated there was no device malfunction. We found no problem with the light cable. All karl storz light cables come with care and maintenance instructions that include the warning statement: "never leave the endoscope connection of the cable laying on a drape with the light source turned on, as surgical drapes may be potentially flammable".
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221826-2007-00001 |
| MDR Report Key | 812756 |
| Report Source | 06 |
| Date Received | 2007-01-11 |
| Device Manufacturer Date | 2004-06-01 |
| Date Added to Maude | 2007-02-07 |
| 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 | 91 CARPENTER HILL, RD. |
| Manufacturer City | CHARLTON MA 01507 |
| Manufacturer Country | US |
| Manufacturer Postal | 01507 |
| Manufacturer Phone | * |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | FFZ |
| Date Received | 2007-01-11 |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 800236 |
| Baseline Brand Name | KARL STORZ |
| Baseline Generic Name | LIGHT CABLE |
| Baseline Model No | 495NCS |
| Baseline Catalog No | 495NCS |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-01-11 |