MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-09-01 for SPARROWHAWK ENDOMYOCARDIAL BIOPSY FORCEPS * 5037 manufactured by Atc Technologies.
[16279540]
Md was performing an endomyocardial biopsy. When using an atc endomyocardial forceps, the md could not open the jaws. Surgeon was called in to assist with removing the catheter from the heart, which was successfully completed. One-time use forceps saved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 636385 |
| MDR Report Key | 636385 |
| Date Received | 2005-09-01 |
| Date of Report | 2005-09-01 |
| Date of Event | 2005-08-08 |
| Report Date | 2005-09-01 |
| Date Reported to FDA | 2005-09-01 |
| Date Added to Maude | 2005-09-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | SPARROWHAWK ENDOMYOCARDIAL BIOPSY FORCEPS |
| Generic Name | FORCEPS |
| Product Code | DWZ |
| Date Received | 2005-09-01 |
| Model Number | * |
| Catalog Number | 5037 |
| Lot Number | 030503 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 625923 |
| Manufacturer | ATC TECHNOLOGIES |
| Manufacturer Address | 80 CUMMINGS PARK WOBURN MA 01801 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2005-09-01 |