MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2007-05-21 for * manufactured by Storz Medical Ag.
[7901630]
Previous to and during this procedure, the operators of the unit noticed it made loud noises and emitted noxious fumes, but the did not call for svc. After it failed, sys was serviced on 3/22/07 for a bad high voltage generator (ltg). Also replaced hv plug on psc and blow flange. What the hosp was reporting, was the interruption.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613347-2007-00013 |
| MDR Report Key | 974257 |
| Report Source | 06,07 |
| Date Received | 2007-05-21 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2008-01-07 |
| 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 | UNTERESEESTRASSE 47 |
| Manufacturer City | KREUZLINGEN CH-8280 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH-8280 |
| 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 | NCV |
| Date Received | 2007-05-21 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 942462 |
| Manufacturer | STORZ MEDICAL AG |
| Manufacturer Address | LOHSTAMPFESTRASSE 8 TAGERWILEN SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-21 |