MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-07-01 for VIDAMED TUNA SYSTEM 6196US * manufactured by Vidamed, Inc..
[110185]
Physician stated transurethral needle ablation needles sticking-not deploying. Left probe appeared bent, sheath caught in head of catheter. New transurethral needle ablation catheter system used, to complete procedures.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1014230 |
| MDR Report Key | 179078 |
| Date Received | 1998-07-01 |
| Date of Report | 1998-07-01 |
| Date of Event | 1998-04-01 |
| Date Added to Maude | 1998-07-29 |
| 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 | VIDAMED TUNA SYSTEM |
| Generic Name | UROLOGIC |
| Product Code | MIK |
| Date Received | 1998-07-01 |
| Model Number | 6196US |
| Catalog Number | * |
| Lot Number | 7PJ030 |
| ID Number | * |
| Device Expiration Date | 1998-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 174127 |
| Manufacturer | VIDAMED, INC. |
| Manufacturer Address | 46107 LANDING PKWY. FREMONT CA 94538 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1998-07-01 |