MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2008-04-30 for DISPOSABLE KOPANS SPRINGHOOK LOCALIZER NEEDLE DKBL-21-9.0-A manufactured by Cook, Inc..
[853821]
Clinic called wanting to know if it is ok for pt to have an mri as the kopans needle had broken off in the pt. Upon further discussion, the reporter stated it had happened in 2007 at another facility. The clinic was advised the product is made of ferrous metal. They will determine what to do at a later time. The pt has not sustained any adverse effect at this time.
Patient Sequence No: 1, Text Type: D, B5
[8062152]
Evaluation: no product or lot info was provided to assist in this investigation. Cook does warn on the labels of this device: "caution when using kopans spring hookwires: following placement of the hookwire, the portion protruding outside of the breast should be bent and taped to the skin to prevent inadvertent movement. Final hookwire position should be confirmed by appropriate imaging modality. Under no circumstances should a hookwire engaged in tissue be pulled out without surgical intervention. The hookwire should be used as a guide for the surgeon, not a retractor. We will continue to monitor for similar events.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2008-00226 |
| MDR Report Key | 1036262 |
| Report Source | 05,07 |
| Date Received | 2008-04-30 |
| Date of Report | 2008-04-02 |
| Date of Event | 2007-06-01 |
| Date Facility Aware | 2008-04-02 |
| Report Date | 2008-04-02 |
| Date Mfgr Received | 2008-04-02 |
| Date Added to Maude | 2008-05-06 |
| 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 |
| 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 | DISPOSABLE KOPANS SPRINGHOOK LOCALIZER NEEDLE |
| Generic Name | FMI NEEDLE |
| Product Code | MIJ |
| Date Received | 2008-04-30 |
| Model Number | NA |
| Catalog Number | DKBL-21-9.0-A |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1004630 |
| Manufacturer | COOK, INC. |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-04-30 |