MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-03-07 for BIOPSY FORCEPS 504302 manufactured by Cordis Corporation.
[821555]
The report received indicated that during the procedure, the biopsy forceps were opened without any trouble; some difficulty was encountered while closing the forceps. However, the product was returned for evaluation and the unit was received with the coil detached. Further investigation was conducted indicating that the physician was able to take one tissue sample successfully; however, when attempting to take a second sample the jaws of the device jammed and remained open. The physician spent over an hour trying to remove the device from the patient; eventually removing the handle and detaching the coil. The device was removed in a "normal" fashion without any adverse event to the patient.
Patient Sequence No: 1, Text Type: D, B5
[8029866]
The product has been returned for evaluation; however, as of to date the evaluation has not been completed. Additional information will be submitted within 30 days upon receipt.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1016427-2008-00058 |
| MDR Report Key | 1009066 |
| Report Source | 05,07 |
| Date Received | 2008-03-07 |
| Date of Report | 2008-01-24 |
| Date of Event | 2008-01-24 |
| Date Mfgr Received | 2008-02-19 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2008-03-13 |
| 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. GAURANG PATEL, MEDICAL DIRECTOR |
| Manufacturer Street | 14201 N.W. 60TH AVENUE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal | 33014 |
| Manufacturer Phone | 7863136240 |
| Manufacturer G1 | CORDIS CORPORATION |
| Manufacturer Street | 14201 N.W. 60TH AVENUE |
| 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 | 2008-03-07 |
| Returned To Mfg | 2008-02-19 |
| Model Number | NA |
| Catalog Number | 504302 |
| Lot Number | 71007253 |
| ID Number | PART #: NA |
| Device Expiration Date | 2010-09-30 |
| 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 | 977900 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | MIAMI LAKES FL 33014 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-03-07 |