FDA Adverse Event
Malfunction
Summary report: N
BIOPSY FORCEPS
MDR report key: 959820
·
Received May 2, 2007
Report
- Report Number
- 1016427-2007-00051
- Event Type
- Malfunction
- Date Received
- May 2, 2007
- Report Date
- April 10, 2007
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DWZ
- PMA / PMN Number
- k951447
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
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.
Description of Event or Problem · 1
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.)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIOPSY FORCEPS | CARDIOLOGY WIRES & METALS (DWZ) | DWZ | CORDIS CORPORATION | NA | 70306298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | INTRODUCTORY CATHETER |