MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2007-07-17 for BIOPSY FORCEPS 504302 manufactured by Cordis Corporation.
[19489294]
The biopsy forceps would not open or close. There was difficulty removing the biopsy forceps from the patient's vasculature. It was forcibly pulled out. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
[19621906]
Additional information will be submitted upon 30 days of receipt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1016427-2007-00075 |
| MDR Report Key | 882094 |
| Report Source | 05,07 |
| Date Received | 2007-07-17 |
| Date of Report | 2007-06-20 |
| Date of Event | 2007-06-17 |
| Date Mfgr Received | 2007-06-20 |
| Device Manufacturer Date | 2007-03-01 |
| Date Added to Maude | 2007-08-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. THOMAS MORRISSEY, MEDICAL DIRECT |
| Manufacturer Street | 14201 N.W. 60TH AVE. |
| Manufacturer City | MIAMI LAKES FL 33014 |
| 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 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOPSY FORCEPS |
| Generic Name | CARDIOLOGY WIRES & METALS (DWZ) |
| Product Code | DWZ |
| Date Received | 2007-07-17 |
| Returned To Mfg | 2007-06-27 |
| Model Number | NA |
| Catalog Number | 504302 |
| Lot Number | 70307263 |
| ID Number | PART #: NA |
| Device Expiration Date | 2010-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867578 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | MIAMI LAKES FL 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-07-17 |