MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-05 for KOPANS BREAST LESION LOCALIZATION NEEDLE G12160 manufactured by Cook, Inc..
[51262800]
Patient Sequence No: 1, Text Type: N, H10
[51262801]
A 20 gauge 5 cm needle placed under mri guidance. Procedure completed. Surgeon pulled back needle to remove it at the end of case and the tip broke off. Provider was unable to retrieve the wire tip, which was disclosed to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5849514 |
| MDR Report Key | 5849514 |
| Date Received | 2016-08-05 |
| Date of Report | 2016-07-29 |
| Date of Event | 2016-07-22 |
| Report Date | 2016-07-29 |
| Date Reported to FDA | 2016-07-29 |
| Date Reported to Mfgr | 2016-07-29 |
| Date Added to Maude | 2016-08-05 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOPANS BREAST LESION LOCALIZATION NEEDLE |
| Generic Name | NEEDLE, TUMOR LOCALIZATION |
| Product Code | MIJ |
| Date Received | 2016-08-05 |
| Catalog Number | G12160 |
| Lot Number | F4181874 |
| Device Expiration Date | 2018-04-01 |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-05 |