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

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

Event Date 09/26/2023

Event Type  malfunction  

Event Description

It was recommended to sterilize the neoprobe devices with the battery in, and as we did this they began to not connect with the console.A recommendation by the vendor was to sterilize them with the battery not in the device so we began to do this, and we have not had any failure to connect.

• 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: 18266191
• MDR Text Key: 329724280
• Report Number: 18266191
• 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
• Type of Report: Initial
• Report Date: 10/02/2023

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
• 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: 10/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male