MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC NEOPROBE; PROBE, UPTAKE, NUCLEAR

Model Number NPB09S

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

The neoprobe npb09s is a reusable gamma detection probe that is cleaned and disinfected and/or sterilized between uses.Based on the review of the dhr, the device was manufactured in oct.2013, and released for commercial use having met all acceptance tests and calibration criteria.The device has not been received at the site of manufacture, nortech.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 malfunction were to reoccur.This potential serious injury would be from an infection due to cross contamination and/or the tip of the neoprobe falling off during the procedure and being left behind in the body.Possible causes of this defect would be deficient expoxy or a loose probe, pursuant to 21 cfr 803, we are deeming this a reportable event and thus submitting this medwatch report.

Event Description

It was reported by the sales rep that after the procedure the probe has a broken tip.The procedure was completed with device with no patient consequence.

• Brand Name: NEOPROBE
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): NORTECH SYSTEMS, INC.; 925 sixth avenue, ne; milaca MN 56353
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7671228
• MDR Text Key: 113510904
• Report Number: 3008492462-2018-00049
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 07/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NPB09S
• Device Catalogue Number: NPB09S
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/04/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1