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 05/11/2017

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 may 2015, and released for commercial use having met all acceptance tests and calibration criteria.The device was received at the site of manufacture, nortech, on may 17, 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, due to the potential for serious injury (potential infection due to cross-contaminations; tip falling off during procedure as a result of deficient epoxy/loose probe tip) if malfunction were to reoccur, 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 tip of the probe came off while they were cleaning it.The procedure was completed with device with no patient consequences.

Manufacturer Narrative

The neoprobe npb09s was evaluated at site of manufacture, nortech (the contract manufacturer of this device).The voc was confirmed.The probe passed service tests.The end cap has come loose and been put back on.The interior of the end cap and union have contamination.Disassembly of the end cap assembly (probe tip) revealed a broken crystal.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.The end cap assembly with union was removed and cleaned old epoxy from handle, replaced end cap assembly with new union, shield, foam washer foam disk and crystal.Probe passed leak tests and all service final functional tests.Probe was then returned to the customer on (b)(4) 2017.Updated to reflect the date that new information was received.Update to reflect that this is a follow-up report.

Event Description

It was reported by the sales rep that after the procedure the tip of the probe came off while they were cleaning it.The procedure was completed with device with no patient consequences.

• 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: 6629290
• MDR Text Key: 77240037
• Report Number: 3008492462-2017-00037
• 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: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• 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: 05/17/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2015
• 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