MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2004-01-12 for UNIVERSAL ACTIVE CORD ACU-1-VL manufactured by Wilson-cook Medical, Inc..
[341398]
The physician used a wilson-cook universal active cord with a competitive snare and a electrocautery unit during a colonoscopy and polypectomy prodedure. When the physician applied current to the snare the snare did not conduct current causing the polyp to be cut instead of cauterized. The physician attempted to use a bicap probe with the same electrocautery unit and the bicap probe did not conduct current. The wilson-cook universal active cord was not required for use of the bicap probe. A second electrocautery unit was used, and the bicap was then successful. The pt was injected with epinephrine and the bleeding stopped. The pt was hospitalized and given three units of blood. Post procedure the pt's condition was reported as good.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1037905-2004-00006 |
| MDR Report Key | 506020 |
| Report Source | 07 |
| Date Received | 2004-01-12 |
| Date of Report | 2003-12-12 |
| Date of Event | 2003-11-14 |
| Date Mfgr Received | 2003-12-12 |
| Date Added to Maude | 2004-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JESSICA HUGHES, MANAGER |
| Manufacturer Street | 4900 BETHANIA STATION RD |
| Manufacturer City | WINSTON-SALEM NC 27105 |
| Manufacturer Country | US |
| Manufacturer Postal | 27105 |
| Manufacturer Phone | 3367440157 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL ACTIVE CORD |
| Generic Name | MISCELLANEOUS |
| Product Code | FFZ |
| Date Received | 2004-01-12 |
| Model Number | NA |
| Catalog Number | ACU-1-VL |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 494889 |
| Manufacturer | WILSON-COOK MEDICAL, INC. |
| Manufacturer Address | 4900 BETHANIA STATION RD. WINSTON-SALEM NC 27105 US |
| Baseline Brand Name | UNIVERSAL ACTIVE CORD |
| Baseline Generic Name | MISCELLANEOUS |
| Baseline Model No | NA |
| Baseline Catalog No | ACU-1-VL |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-01-12 |