MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2018-09-10 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-21-9.0-A manufactured by Cook Inc.
[119666279]
(b)(6). Pma/510(k) #: exempt. 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
[119666280]
It was reported that a kopans modified breast lesion localization needle was inserted into the patient via stereotactic guidance prior to a procedure. Post wire mammograms were then performed without complication. The wire was secured to the patient after the mammogram. As the patient walked to another room, the wire broke in two, leaving one end still anchored in the patient's breast. The radiologist secured the small external piece of the wire with tape upon noticing the wire had broken. A second wire was required which was unrelated to the first wire breaking, and upon insertion, the radiologist noticed that the first wire had broken at the proximal end near the hub. A second series of post wire mammogram showed both the intact and broken wires. Both wires were successfully removed during the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-02675 |
| MDR Report Key | 7859796 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-09-10 |
| Date of Report | 2018-12-04 |
| Date of Event | 2018-08-24 |
| Date Mfgr Received | 2018-11-13 |
| Device Manufacturer Date | 2017-07-19 |
| Date Added to Maude | 2018-09-10 |
| 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 | 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 | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| 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 | 2018-09-10 |
| Returned To Mfg | 2018-10-10 |
| Model Number | NA |
| Catalog Number | DKBL-21-9.0-A |
| Lot Number | 8077392 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-09-10 |