MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-11-03 for CONTINENTAL UROMAT UROMAT 2000,TM40 RF-GENERATOR G9340-GENERATOR manufactured by Trex Medical Corp..
[74390]
Pt in or for cysto-retrograde & positioning of stent procedure. During procedure the fluroscopy failed, switches to conventional x-ray rptr was unable to take regular x-ray due to malfunction of the x-ray generator. These malfunctions made it difficult to complete. During procedure the generator displayed "system 33 flag error" "high kv".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012442 |
| MDR Report Key | 130717 |
| Date Received | 1997-11-03 |
| Date of Report | 1997-10-29 |
| Date of Event | 1997-10-09 |
| Date Added to Maude | 1997-11-12 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTINENTAL UROMAT |
| Generic Name | RADIOGRAPHIC FLUOROSCOPIC |
| Product Code | MMZ |
| Date Received | 1997-11-03 |
| Model Number | UROMAT 2000,TM40 RF-GENERATOR |
| Catalog Number | G9340-GENERATOR |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 127833 |
| Manufacturer | TREX MEDICAL CORP. |
| Manufacturer Address | 2000 S 25TH AVE BROADVIEW IL 60153 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 1997-11-03 |