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

Model Number NPB09S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/20/2017

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 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.

Event Description

It was reported by the sales rep that after a breast biopsy procedure, tip of probe broke off.

Manufacturer Narrative

The neoprobe npb09s was evaluated at site of (b)(4) (the contract manufacturer of this device).The voc was confirmed.The probe was returned with the end cap missing.The deficiencies associated with this event are indicative of the device being dropped.However, we were unable to confirm if the device had been dropped.Old epoxy was removed from the union end.The end cap assembly was replaced with new components: union, stop nut, backshield, teflon cup, contact shield, contact, foam disk, crystal, foam washer, 1104 washer, tungsten shield and end cap.Replaced snapdome after cleaning contacts.Removed old keypad and old epoxy.Replaced with new rev c keypad.Reassembled probe and passed pre-epoxy test.Applied epoxy.Probe passed leak tests and all service final functional tests.Probe was then returned to the customer on (b)(6) 2017.Updated to reflect the date that new information was received.Updated to reflect the date the new information was received.Updated to reflect that this is a follow-up report.

Event Description

It was reported by the sales rep that after a breast biopsy procedure, tip of probe broke off.

• Brand Name: NEOPROBE
• Type of Device: GAMMA UPTAKE PROBE
• 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: 6722245
• MDR Text Key: 80425577
• Report Number: 3008492462-2017-00047
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510K EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/24/2013
• 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