MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS BREAST BIOPSY SITE MARKER; NEOPROBE

Model Number BLUETOOTH II

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2017

Event Type  malfunction  

Event Description

Circulator and lunch relief scrub tech with doctors were performing sentinel node biopsy.We successfully linked neoprobe at beginning of case and worked for first node.We were able to use to find second node and while getting ex-vivo count neoprobe stopped working.

• Brand Name: BREAST BIOPSY SITE MARKER
• Type of Device: NEOPROBE
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 7066769
• MDR Text Key: 93204115
• Report Number: 7066769
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/15/2017

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: Physician
• Device Model Number: BLUETOOTH II
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/15/2017
• Event Location: Hospital
• Date Report to Manufacturer: 11/15/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 95