MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-05-16 for MAXXIM MEDICAL BIOPSY FORCEP "JAWS" * 190031 manufactured by Maxxim Medical.
[229866]
The doctor made two successful passes with this forcep. Jugular approach got two successful samples. Third into right ventricle. Through the valve, opened with no problem. Forcep tip against ventricle wall and jaws would not open. Jaws had engaged some tissue and the physician tugged until the jaw removed itself peeled endomyscardial tissue. Pathology confirmed that it was endo tissue and not in valve.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2002-00007 |
| MDR Report Key | 395531 |
| Report Source | 05 |
| Date Received | 2002-05-16 |
| Date Mfgr Received | 2002-04-17 |
| Device Manufacturer Date | 2002-03-01 |
| Date Added to Maude | 2002-05-23 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1445 FLAT CREEK ROAD |
| Manufacturer City | ATHENS TX 75751 |
| Manufacturer Country | US |
| Manufacturer Postal | 75751 |
| Manufacturer Phone | 9036779311 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAXXIM MEDICAL BIOPSY FORCEP "JAWS" |
| Generic Name | BIOPSY FORCEP |
| Product Code | DWZ |
| Date Received | 2002-05-16 |
| Model Number | * |
| Catalog Number | 190031 |
| Lot Number | 020247 |
| ID Number | * |
| Device Expiration Date | 2007-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 384537 |
| Manufacturer | MAXXIM MEDICAL |
| Manufacturer Address | 1445 FLAT CREEK ROAD ATHENS TX 75751 US |
| Baseline Brand Name | MAXXIM MEDICAL BIOPSY FORCEP "JAWS" |
| Baseline Generic Name | BIOPSY FORCEP |
| Baseline Model No | NA |
| Baseline Catalog No | 190031 |
| Baseline ID | NA |
| Baseline Device Family | BIOPSY FORCEP |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K896146 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-05-16 |