MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. NEOPROBE; PROBE, UPTAKE, NUCLEAR

Model Number NPR14

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

Event Date 09/29/2023

Event Type  malfunction  

Event Description

Probe not linking to neoprobe device when plugged in.Unable to use device.The device was broken/melted upon opening the tray.Instrument was disassembled incorrectly, and wires were exposed during sterilization.Wires were melted and cable and cord were disconnected from the tip of the instrument.It was unusable.

• Brand Name: NEOPROBE
• Type of Device: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 18695554
• MDR Text Key: 335254222
• Report Number: 18695554
• Device Sequence Number: 1
• Product Code: IZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Report Date: 10/06/2023

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: NPR14
• Device Catalogue Number: NPR14
• Device Lot Number: G614214602
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1