MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-07-18 for NEOPROBE NPB09S manufactured by Devicor Medical Products, Inc..
[80425577]
The neoprobe npb09s is a reusable gamma detection probe that is cleaned and disinfected and/or sterilized between uses. Based on review of the dhr, the device was manufactured in december 2013 and released for commercial use having met all acceptance tests and calibration criteria. The device was received at the site of manufacture, (b)(4), on june 28, 2017. The device is currently in the evaluation process. A supplemental report will be submitted once the evaluation is complete. While there was no adverse effect during this event, there is a potential for serious injury if the malfunction were to recur. This potential serious injury would be from an infection due to cross contamination and/or the tip of the neoprobe probe falling off during the procedure and being left behind in the body. Possible causes of this defect would be deficient epoxy or a loose probe tip. Both of these potential serious injuries could require a subsequent surgical procedure. Pursuant to 21 cfr 803, we are deeming this a reportable event and thus submitting this medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[80425578]
It was reported by the sales rep that after a breast biopsy procedure, tip of probe broke off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008492462-2017-00047 |
| MDR Report Key | 6722245 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-07-18 |
| Date of Report | 2017-08-07 |
| Date of Event | 2017-06-20 |
| Date Mfgr Received | 2017-08-07 |
| Device Manufacturer Date | 2013-12-24 |
| Date Added to Maude | 2017-07-18 |
| 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 | MS. SHAWNA ROSE |
| Manufacturer Street | 300 E-BUSINESS WAY FIFTH FLOOR |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer Phone | 5138649178 |
| Manufacturer G1 | NORTECH SYSTEMS, INC. |
| Manufacturer Street | 925 SIXTH AVENUE, NE |
| Manufacturer City | MILACA MN 56353 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 56353 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOPROBE |
| Generic Name | GAMMA UPTAKE PROBE |
| Product Code | IZD |
| Date Received | 2017-07-18 |
| Returned To Mfg | 2017-06-28 |
| Model Number | NPB09S |
| Catalog Number | NPB09S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEVICOR MEDICAL PRODUCTS, INC. |
| Manufacturer Address | 300 E-BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-07-18 |