MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-24 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A UNKNOWN manufactured by Cook Inc.
[48858983]
(b)(4). This event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[48858984]
The surgeon was cauterizing around the lesion and the kopans melted.
Patient Sequence No: 1, Text Type: D, B5
[54899631]
Blank fields on this form indicate the information is unknown or unavailable. (b)(4). Investigation results - a review of the complaint history, manufacturing instructions (mi) and quality control (qc) documents was conducted for the purpose of this investigation. The product involved in this complaint has not been returned for evaluation. In addition, the product catalog and lot number are unknown and no images of the device(s) in question were provided. As such, a full investigation cannot be performed. The complaint is based off of the testimony provided by the customer. Kopans breast localization needles are produced per drawing according to instructions found in manufacturing instructions. Final inspection of the device is performed according per qc. Because the device was not returned, no images were provided, and the product rpn was not reported, a full investigation could not be performed and the complaint could not be confirmed via objective evidence. There are no signs that the device contained a manufacturing nonconformity. There is no evidence to suggest the device was not manufactured to specifications. A definitive root cause could not be determined. The root cause of this complaint is inconclusive. We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.
Patient Sequence No: 1, Text Type: N, H10
[54899632]
During the procedure, the surgeon was cauterizing around the lesion and the kopans melted. Additional information was requested, however it was not provided at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00530 |
| MDR Report Key | 5748636 |
| Date Received | 2016-06-24 |
| Date of Report | 2016-06-06 |
| Date Mfgr Received | 2016-06-06 |
| Date Added to Maude | 2016-06-24 |
| 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 | 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 | 2016-06-24 |
| Model Number | N/A |
| Catalog Number | UNKNOWN |
| 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 | 2016-06-24 |