MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2017-12-12 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-20-9.0-A manufactured by Cook Inc.
[94477723]
(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
[94477724]
The international customer reported that the wire included in the kopans modified breast lesion localization needle set had dislodged from the patient. The device had been placed prior to a scheduled lumpectomy, and the product issue was noticed once the patient reached the operating room. At this point, the patient was rescheduled for another procedure. Additional information has been requested from the customer, but none has yet been provided. The device is reportedly unavailable for return.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2017-04361 |
| MDR Report Key | 7107559 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2017-12-12 |
| Date of Report | 2018-03-07 |
| Date Mfgr Received | 2018-02-27 |
| Device Manufacturer Date | 2016-08-16 |
| Date Added to Maude | 2017-12-12 |
| 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 |
| 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 | 2017-12-12 |
| Model Number | N/A |
| Catalog Number | DKBL-20-9.0-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. Required No Informationntervention | 2017-12-12 |