MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-27 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-21-9.0-A manufactured by Cook Inc.
[103567521]
(b)(4). 510k status: exempt, preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[103567522]
The international customer reported that, during a hook wire localization of malignant lesion in left breast in which the kopans modified breast lesion localization needle was employed, the hook portion of the product broke off and was left in the patient's pectoralis muscle. The physician had initially inserted a hook wire, but the post procedure mammogram did not show the location of the hook inside the lesion. A second hook wire was then inserted which did properly mark the lesion, and the surgeon was informed about the use of two wires. The second hook wire was removed with no issued along with the lesion during the surgery, but it was during the removal of the first hook wire that the hook became lodged in the patient's muscle. The rest of the wire was retrieved as expected; only the 1 cm portion of the hook wire was retained. Imaging later confirmed the location of the retained piece of the device. The complaint device is reportedly unavailable for return and evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-00745 |
| MDR Report Key | 7373753 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-27 |
| Date of Report | 2018-04-13 |
| Date of Event | 2018-01-31 |
| Date Mfgr Received | 2018-03-16 |
| Device Manufacturer Date | 2017-01-24 |
| Date Added to Maude | 2018-03-27 |
| 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 | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE |
| Generic Name | MIJ NEEDLE, TUMOR LOCALIZATION |
| Product Code | MIJ |
| Date Received | 2018-03-27 |
| Model Number | N/A |
| Catalog Number | DKBL-21-9.0-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Other | 2018-03-27 |