MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-05-03 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-21-5.0-A manufactured by Cook, Inc..
[19578116]
During surgery, the physician held the wire up to make the incision and the wire came out. A review noted the hook was no longer present; the hook was still in the breast tissue. The tissue sample was removed and the physician was able to remove the hook from the pt; everything was removed from the pt. There was no harm to the pt reported. The localization is inserted prior to surgery and everything removed during the surgery.
Patient Sequence No: 1, Text Type: D, B5
[19593715]
(b)(4): removal of foreign body is not listed in the instructions for use. Separates is not listed in the instructions for use. Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00237 |
| MDR Report Key | 2572748 |
| Report Source | 06 |
| Date Received | 2012-05-03 |
| Date of Report | 2012-04-13 |
| Date of Event | 2012-03-19 |
| Date Facility Aware | 2012-03-19 |
| Report Date | 2012-04-13 |
| Date Mfgr Received | 2012-04-13 |
| Device Manufacturer Date | 2011-09-07 |
| Date Added to Maude | 2012-05-15 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | RITA HARDEN, MGR |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE |
| Generic Name | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-05-03 |
| Returned To Mfg | 2012-04-24 |
| Model Number | NA |
| Catalog Number | DKBL-21-5.0-A |
| Lot Number | 2809311 |
| ID Number | NA |
| Device Expiration Date | 2016-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-05-03 |