MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-09-05 for 11GA EX MAMMATOME PROBE HH11BEX * manufactured by Ethicon Endo Surgery Johnson & Johnson.
[17037336]
During the mammatome biopsy procedure after taking two passes the probe quit working. The orginal two passes did not produce any specimens. We could not close the probe it would only go half way and stop. We tried in position, sample and clearing modes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 758627 |
| MDR Report Key | 758627 |
| Date Received | 2006-09-05 |
| Date of Report | 2006-09-01 |
| Date of Event | 2006-08-30 |
| Date Facility Aware | 2006-08-30 |
| Report Date | 2006-09-01 |
| Date Reported to Mfgr | 2006-09-01 |
| Date Added to Maude | 2006-09-12 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 11GA EX MAMMATOME PROBE |
| Generic Name | HH11BEX |
| Product Code | FCI |
| Date Received | 2006-09-05 |
| Model Number | HH11BEX |
| Catalog Number | * |
| Lot Number | C4EM9X |
| ID Number | * |
| Device Expiration Date | 2011-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 746552 |
| Manufacturer | ETHICON ENDO SURGERY JOHNSON & JOHNSON |
| Manufacturer Address | 1113 SPRINGSIDE CT LOUISVILLE KY 40223 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-09-05 |