MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-01 for NEOPROBE NPB09S manufactured by Devicor Medical Products, Inc.
[69153255]
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 october 2013, and released for commercial use having met all acceptance tests and calibration criteria. There is no history of device having been serviced since it's production. Device was evaluated at site of manufacture, (b)(4) (the contract manufacturer of this device). The unit was received in an unprotected/unsecured foam lined box. There is evidence that during transit, that the unit damage was caused by hitting some object or being dropped. That the box was hit hard enough to dent the cardboard. The crystal was found to be damaged and need to be replaced. The thin section of the end cap assembly is missing in the joint area. Not known if caused during shipment or through normal repeated use. Epoxy was present fully in the threads. The crystal was found to be damaged and will need to be replaced. The deficiencies associated with this even are indicative of the device being dropped. Followup communication with the customer indicated that the tip of the probe was loose. However, they were able to tighten and use during procedure. The tip did not fall off during use on a patient. We were unable to confirm if device had been dropped. While no adverse effect during this event, due to the potential for serious injury (potential infection due to cross-contamination; tip falling off during procedure as a result of deficient epoxy/loose probe tip) if malfunction were to reoccur, pursuant to 21cfr 803, we are deeming this a reportable event and thus submitting this medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[69153256]
It was reported by the sales rep that during an o. R. Procedure the probe tip has broken off of bt probe. They can screw it back on, but it needs to be re-sealed. The procedure was completed with the original device with no patient consequence.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008492462-2017-00008 |
| MDR Report Key | 6370925 |
| Date Received | 2017-03-01 |
| Date of Report | 2017-01-31 |
| Date of Event | 2017-01-31 |
| Date Mfgr Received | 2017-01-31 |
| Device Manufacturer Date | 2013-10-04 |
| Date Added to Maude | 2017-03-01 |
| 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 | 0 |
| Brand Name | NEOPROBE |
| Generic Name | GAMMA UPTAKE PROBE |
| Product Code | IZD |
| Date Received | 2017-03-01 |
| Returned To Mfg | 2017-02-27 |
| Model Number | NPB09S |
| Catalog Number | NPB09S |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2017-03-01 |