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 2018-06-08 for KOPANS MODIFIED BREAST LESION LOCALIZATION NEEDLE DKBL-20-9.0-A manufactured by Cook Inc.
[110508122]
(b)(4). Pma/510(k) #: preamendment. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[110508123]
It was reported a kopans modified breast lesion localization needle was not in the correct place for the surgeon. The patient was taken from the operating room to radiology where the radiologist placed a second marker. As reported, this incident caused a delay in the procedure, however, the patient did not experience any adverse effects due to this occurrence.
Patient Sequence No: 1, Text Type: D, B5
[117479275]
Additional information was received on 20jun2018. It was determined this mfr. Report : 1820334-2018-01669 and mfr. Report: 1820334-2018-01663 are duplicate reports. The same patient, same device, one complaint. The patient had 2 tumors, one in the left breast and 1 in the right breast. One hook was implanted correctly, the issue occurred for one breast only. This event will be filed under mfr. Report: 1820334-2018-01663. Please cancel mfr. Report: 1820334-2018-01669 as a duplicate complaint.
Patient Sequence No: 1, Text Type: N, H10
[117479276]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-01669 |
| MDR Report Key | 7582398 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-06-08 |
| Date of Report | 2018-08-17 |
| Date of Event | 2018-04-24 |
| Date Mfgr Received | 2018-08-01 |
| Device Manufacturer Date | 2018-02-05 |
| Date Added to Maude | 2018-06-08 |
| 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 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| 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 | 2018-06-08 |
| Catalog Number | DKBL-20-9.0-A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2018-06-08 |