MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-12-20 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE N/A DKBL-20-5.0-A manufactured by Cook Inc.
[62838245]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[62838246]
It was reported during a left partial mastectomy with needle localization procedure when the specimen was removed and sent to radiology and pathology, the radiologist reported that the localization wire was not in the specimen. After careful examination, it was determined that the wire was still in the patient and was migrating. The migration of the wire was tracked and a surgeon was able to remove the wire surgeon by pulling it our manually through the initial incision. The manual removal caused additional surgery time under general anesthesia and fluoroscopy. 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
[78169430]
Investigation - evaluation a review of the drawings, manufacturing instructions and quality control was conducted during the investigation. The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The lot number of the device is not known; accordingly a review of the device history record could not be conducted. Based on the information provided, no product returned 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 | 1820334-2016-01524 |
| MDR Report Key | 6188751 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-12-20 |
| Date of Report | 2017-05-31 |
| Date of Event | 2016-09-23 |
| Date Mfgr Received | 2017-03-08 |
| Date Added to Maude | 2016-12-20 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2016-12-20 |
| Model Number | N/A |
| Catalog Number | DKBL-20-5.0-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. Required No Informationntervention | 2016-12-20 |