MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2007-05-02 for BIOPSY FORCEPS 504300L manufactured by Cordis Corporation.
[21696033]
The report received from the affiliate indicated that during an endomyocardial biopsy, the 7f biopsy forceps was unable to close and the device appeared damaged. Further information indicated that the device presented the failure when clamping the sample and the forceps could not be closed. When the forceps were removed from the catheter, the jaw assembly seemed to be damaged (which was described as ruptured. )
Patient Sequence No: 1, Text Type: D, B5
[21823916]
The product is available for evaluation; however, as of to date, it has not been returned. Additional information will be submitted within 90 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1016427-2007-00051 |
| MDR Report Key | 959820 |
| Report Source | 01,05,07 |
| Date Received | 2007-05-02 |
| Date of Report | 2007-04-10 |
| Date Mfgr Received | 2007-04-10 |
| Device Manufacturer Date | 2006-03-01 |
| Date Added to Maude | 2007-12-07 |
| 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 | DR. THOMAS MORRISSEY, MEDICAL DIR |
| Manufacturer Street | 14201 N.W. 60TH AVE. |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863132516 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 N.W. 60TH AVE. |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPSY FORCEPS |
| Generic Name | CARDIOLOGY WIRES & METALS (DWZ) |
| Product Code | DWZ |
| Date Received | 2007-05-02 |
| Model Number | NA |
| Catalog Number | 504300L |
| Lot Number | 70306298 |
| ID Number | PART # : NA |
| Device Expiration Date | 2009-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 930032 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | * MIAMI LAKES FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-02 |