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 01/31/2017

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 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.

Event Description

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.

• 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: 6370925
• MDR Text Key: 69153255
• Report Number: 3008492462-2017-00008
• 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
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 02/27/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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