MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2016-08-03 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-21-7.0-A manufactured by Cook Inc.
[51016206]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[51016207]
Per (b)(4), reported through the fda voluntary event reporting process, the manufacturer was informed that during a wire localized partial mastectomy on a (b)(6) female patient, the tip of a breast lesion localization wire broke inside the patient's breast. The provider was unable to locate and retrieve the tip when performing surgery. This was disclosed to the patient.
Patient Sequence No: 1, Text Type: D, B5
[65729825]
Device product code: mij needle, tumor localization. Investigation results- a review of complaint history, manufacturing instructions, quality control measures, specifications and a review of trends was conducted to assist in the investigation. The device will not be returned to aid in the investigation of the alleged product failure. Since the device was not returned, examination could not be performed. Complaint will be confirmed based on customers testimony. This is the only complaint for this failure from 01jan2013 to 19oct2016 for this device. A definitive root cause could not be determined. The device history record was reviewed and no non-conformances were noted. There is no evidence to suggest that device was not manufactured according to specification. We will continue to monitor for similar complaints and have notified the appropriate personnel of this event. Per risk assessment no further actions are necessary at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-00700 |
| MDR Report Key | 5842796 |
| Report Source | OTHER |
| Date Received | 2016-08-03 |
| Date of Report | 2016-07-07 |
| Date of Event | 2016-06-16 |
| Date Mfgr Received | 2016-07-07 |
| Device Manufacturer Date | 2016-03-11 |
| Date Added to Maude | 2016-08-03 |
| 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 | MRS. RITA HARDEN |
| 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 | 2016-08-03 |
| Model Number | N/A |
| Catalog Number | DKBL-21-7.0-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; 2. Required No Informationntervention | 2016-08-03 |