MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-03-23 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-20-5.0-A manufactured by Cook Inc.
[70644584]
(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
[70644585]
International customer reported that a patient underwent a breast excision on (b)(6) 2016 with placement of a kopans modified breast lesion localization needle. The patient presented to the clinic on (b)(6) 2017 with a complaint that a section of the wire came out of her breast. The surgical site was examined and reportedly "everything is fine and no infection" was found. The patient gave the externalized section of the needle to the physician. The circumstances and handling of the device for two months post breast excision are not known. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
[96167568]
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, trends, quality control and visual inspection of the returned device was conducted during the investigation. The customer returned only the hookwire component of a kopans modified breast lesion localization needle; the needle portion of the device was not returned. The hookwire was returned in a used condition. Initial visual inspection confirmed that some biomatter was present on the device. A portion of the wire was broken off and was not returned with the device. A document based investigation evaluation was also performed. There is no evidence to suggest the product was not made to specifications. Review of device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. The device is shipped with an instruction for use (ifu) that describes the intended use; specific items are addressed such as: "precautions: the product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. Standard techniques for localization of breast lesions should be employed. 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 an appropriate imaging modality. Instructions for use: 1. Introduce the needle into the lesion. 2. Check the position of the needle. 3. Advance and release the hookwire. 4. Remove the needle. 5. Bend the hookwire protruding from the breast and tape flat to the skin. 6. Verify final hookwire position. " based on the information provided, examination of the returned partial product and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2017-00542 |
| MDR Report Key | 6427462 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-23 |
| Date of Report | 2017-12-22 |
| Date of Event | 2017-02-16 |
| Date Mfgr Received | 2017-12-06 |
| Device Manufacturer Date | 2016-09-12 |
| Date Added to Maude | 2017-03-23 |
| 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 | 2017-03-23 |
| Model Number | N/A |
| Catalog Number | DKBL-20-5.0-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-23 |