MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-21 for CIRCON GDAC manufactured by Circon Corp.
[19168749]
Endometrial ablation procedure started with resectoscope. After several passes with the resectoscope, the physician stopped. He stated that they were shocked. Black marks were noted on their right glove and portion of the resectoscope that connects to the disposable active cord. The cord had been connected by the physician.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 395639 |
| MDR Report Key | 395639 |
| Date Received | 2002-05-21 |
| Date of Report | 2002-04-09 |
| Date of Event | 2002-04-09 |
| Date Facility Aware | 2002-04-09 |
| Report Date | 2002-04-09 |
| Date Reported to FDA | 2002-05-20 |
| Date Reported to Mfgr | 2002-05-15 |
| Date Added to Maude | 2002-05-23 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCON |
| Generic Name | CIRCON DAC |
| Product Code | FFZ |
| Date Received | 2002-05-21 |
| Model Number | GDAC |
| Catalog Number | GDAC |
| Lot Number | CF6609 |
| ID Number | * |
| Device Expiration Date | 2007-03-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 384645 |
| Manufacturer | CIRCON CORP |
| Manufacturer Address | 6500 HOLLISTER AVE SANTA BARBARA CA 931173019 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-21 |