MAUDE Adverse Event Report: INTRAMEDICAL IMAGING LLC NODE SEEKER; SEED DETECTOR

Model Number INTRAMEDICAL IMAGING S# IMI-NS-1

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/23/2015

Event Type  malfunction  

Event Description

During a right total mastectomy and sentinel node biopsy, the wireless node seeker probe malfunctioned.The wireless node seeker probe would not sync with the node seeker control unit.As a result, the operation was prolonged while obtaining a functioning node seeker probe from another location.The node seeker probe was sent to the manufacturer.

• Brand Name: NODE SEEKER
• Type of Device: SEED DETECTOR
• Manufacturer (Section D): INTRAMEDICAL IMAGING LLC; hawthorne CA 90250
• MDR Report Key: 5267523
• MDR Text Key: 32750189
• Report Number: MW5058289
• Device Sequence Number: 1
• Product Code: IZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INTRAMEDICAL IMAGING S# IMI-NS-1
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR