MAUDE Adverse Event Report: MAMMOTOME / DEVICOR MEDICAL PRODUCTS, INC. NEOPROBE GAMMA DETECTION SYSTEM; PROBE, UPTAKE, NUCLEAR

Device Problems Failure to Reset (1532); Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2022

Event Type  malfunction  

Event Description

Neoprobe probe "froze" upon attempt to use during procedure.Attempts to reset failed.Did not perform as intended.Procedure could not be performed; patient procedure cancelled.

• Brand Name: NEOPROBE GAMMA DETECTION SYSTEM
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): MAMMOTOME / DEVICOR MEDICAL PRODUCTS, INC.
• MDR Report Key: 15543680
• MDR Text Key: 301287684
• Report Number: MW5112437
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White