MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2017-12-07 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-20-15.0-A manufactured by Cook Inc.
[94162052]
510k status: preamendment. (b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[94162053]
The international customer reported that attempts were made to "localise a lesion" [sic]; however, following a discussion with the radiologist and the surgeon it was decided that the area did not need to be localized. The wire of a kopans modified breast lesion localization needle reportedly broke in the patient's breast "at the short hook turn" [sic]. This approximately 9 mm portion of the hook wire was left in the breast of the patient. The remaining complaint product is reportedly available for return; however, as of the date of this report, the device has not yet been received for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-04152 |
| MDR Report Key | 7097457 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2017-12-07 |
| Date of Report | 2018-02-19 |
| Date of Event | 2017-10-17 |
| Date Mfgr Received | 2018-01-24 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2017-12-07 |
| 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 | 2017-12-07 |
| Model Number | N/A |
| Catalog Number | DKBL-20-15.0-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Required No Informationntervention | 2017-12-07 |