MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-11-02 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-20-5.0-A manufactured by Cook Inc.
[90937375]
(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
[90937376]
The international customer reported that, during placement of the hook wire portion of the kopans modified breast lesion localization needle, part of the external wire reportedly snapped off in the radiologist's hands as the device was being secured to the patient's chest with a dressing. To secure the device, it is reportedly common practice to bend the external wire a little. The patient underwent a scheduled procedure on the same day, during which the patient's lump was resected and the complaint product was to be retrieved; it was then discovered during this procedure that the a section of wire had also fractured just under the patient's skin as well. The operator removed both the hook wire and the discovered wire fragment from the patient. All fragments of the wire were ultimately recovered. The device is reportedly available for return; however, as of the date of this report, no device has yet been received for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-03791 |
| MDR Report Key | 6996304 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-11-02 |
| Date of Report | 2018-02-21 |
| Date of Event | 2017-10-18 |
| Date Mfgr Received | 2018-01-25 |
| Device Manufacturer Date | 2017-06-01 |
| Date Added to Maude | 2017-11-02 |
| 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 | 2017-11-02 |
| Model Number | N/A |
| Catalog Number | DKBL-20-5.0-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2017-11-02 |