NEOPROBE NPB09S

MAUDE Adverse Event Report

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 2017-09-07 for NEOPROBE NPB09S manufactured by Devicor Medical Products, Inc..

Event Text Entries

[85138743] 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 (b)(6) 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 (b)(6) 2017. The device is currently in the evaluation process. A supplemental report will be submitted once the evaluation is complete. Further follow-up with customer indicated that the device was not in use in a procedure when the probe tip fell off. They were unable to confirm if the device had been dropped or knocked against another object but, did state that the probe was identified to have been damaged in sterile storage. 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


[85138744] It was reported by the affiliate that the tip has broken off probe.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3008492462-2017-00067
MDR Report Key6848803
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2017-09-07
Date of Report2017-08-15
Date of Event2017-08-15
Date Mfgr Received2017-08-15
Device Manufacturer Date2013-05-20
Date Added to Maude2017-09-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. SHAWNA ROSE
Manufacturer Street300 E-BUSINESS WAY FIFTH FLOOR
Manufacturer CityCINCINNATI OH 45241
Manufacturer CountryUS
Manufacturer Postal45241
Manufacturer Phone5138649178
Manufacturer G1NORTECH SYSTEMS, INC.
Manufacturer Street925 SIXTH AVENUE, NE
Manufacturer CityMILACA MN 56353
Manufacturer CountryUS
Manufacturer Postal Code56353
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameNEOPROBE
Generic NameGAMMA UPTAKE PROBE
Product CodeIZD
Date Received2017-09-07
Returned To Mfg2017-08-21
Model NumberNPB09S
Catalog NumberNPB09S
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDEVICOR MEDICAL PRODUCTS, INC.
Manufacturer Address300 E-BUSINESS WAY FIFTH FLOOR CINCINNATI OH 45241 US 45241


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-07

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