MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-05-03 for ENDOMYCARDIAL BIOPSY FORCEP 190031 manufactured by Maxxim Medical.
[191794]
During the procedure the doctor was unable to close the jaws and had to do a cut down to remove the forcep.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1625425-2000-00004 |
| MDR Report Key | 276623 |
| Report Source | 07 |
| Date Received | 2000-05-03 |
| Date of Report | 2000-05-03 |
| Date of Event | 2000-04-04 |
| Date Facility Aware | 2000-04-04 |
| Report Date | 2000-04-04 |
| Date Mfgr Received | 2000-04-04 |
| Device Manufacturer Date | 2000-02-01 |
| Date Added to Maude | 2000-05-10 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | ENDOMYCARDIAL BIOPSY FORCEP |
| Generic Name | BIOPSY FORCEP |
| Product Code | DWZ |
| Date Received | 2000-05-03 |
| Model Number | NA |
| Catalog Number | 190031 |
| Lot Number | 020006 |
| ID Number | NA |
| Device Expiration Date | 2005-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 267751 |
| 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 | 1. Required No Informationntervention | 2000-05-03 |