MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2001-03-15 for USA ELITE/USA SERIES DISPOSABLE ACTIVE CORD DAC manufactured by Circon Acmi.
[236011]
A turp procedure was being performed on the pt. Frayed cord on bovie electrical connection to the cutting loop. Open electrical wire burned glove and the surgeon's hand at the right index knuckle. Reported to the dept supervisor. Changed to new cord and procedure continued. No injury to the pt. Physician sustained burn approx 1/2 inch around. Medication applied.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1519132-2001-00017 |
| MDR Report Key | 322116 |
| Report Source | 06 |
| Date Received | 2001-03-15 |
| Date of Report | 2001-03-15 |
| Date of Event | 2000-12-27 |
| Date Added to Maude | 2001-03-27 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MARY PICKARD |
| Manufacturer Street | 300 STILLWATER AVE |
| Manufacturer City | STAMFORD CT 06902 |
| Manufacturer Country | US |
| Manufacturer Postal | 06902 |
| Manufacturer Phone | 2033288721 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | USA ELITE/USA SERIES DISPOSABLE ACTIVE CORD |
| Generic Name | 500 |
| Product Code | FFZ |
| Date Received | 2001-03-15 |
| Model Number | DAC |
| Catalog Number | DAC |
| Lot Number | NI |
| 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 | 311618 |
| Manufacturer | CIRCON ACMI |
| Manufacturer Address | 93 NORTH PLEASANT ST. NORWALK OH 448570409 US |
| Baseline Brand Name | DISPOSABLE ACTIVE CORD |
| Baseline Generic Name | ACTIVE CORD |
| Baseline Model No | DAC |
| Baseline Catalog No | DAC |
| Baseline ID | NA |
| Baseline Device Family | ACTIVE CORD |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-15 |