MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2012-11-20 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-7.0-A manufactured by Cook, Inc..
[16910635]
The hook broke off inside the patient. The customer contacted customer service during the procedure requesting to talk with someone who could advise how to proceed. Customer service contacted the district manager and transferred the call. Per the district manager: the patient was in surgery. The district manager advised the surgeon while excising the lesion to proceed and remove the spring hook. The surgeon inquired if it was safe to leave in and district manager advised not to and to remove it. The surgeon advised she would proceed. Update on (b)(6) 2012 - per the district manager: unsure why the hook broke off, the patient was in surgery, so the hook was removed while there. No lot number obtained. A section of the device did not remain inside the patient's body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[16949994]
Expiration date unknown as lot # is unknown. (b)(4). Manufacture date unknown as lot # is unknown. Event is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2012-00540 |
| MDR Report Key | 2896002 |
| Report Source | 06 |
| Date Received | 2012-11-20 |
| Date of Report | 2012-11-01 |
| Report Date | 2012-11-01 |
| Date Mfgr Received | 2012-11-02 |
| Date Added to Maude | 2013-01-17 |
| 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 | RITA HARDEN, MANAGER |
| 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 | DWO NEEDLE, BIOPSY, CARDIOVASCULAR |
| Product Code | DWO |
| Date Received | 2012-11-20 |
| Model Number | NA |
| Catalog Number | DKBL-20-7.0-A |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-11-20 |