MAUDE Adverse Event Report: Hologic Cambridge Sentimag SMP02 Probe Assembly; Lymph Node Location System During Sentinel Biopsy Procedure

Model Number	SMP02
Medical Device Problem Code	Imprecise or Erratic Results (4059)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the user site that the "probe has cracked tip and has given erratic readings." the issue was identified during the procedure.The procedure was completed successfully using another device.No patient or user harm was reported, and no additional medical or surgical intervention was required.
Additional Manufacturer Narrative
Device history record (dhr) review was unable to be conducted for the device at the time of this report.A follow-up report will be submitted in the event additional information is received.

• Brand Name: Sentimag SMP02 Probe Assembly
• Common Device Name: Lymph Node Location System During Sentinel Biopsy Procedure
• Manufacturer (Section D): Hologic Cambridge; 330 cambridge science park; cambridge ; UK
• Manufacturer (Section G): Hologic Cambridge; 330 cambridge science park; cambridge ; UK
• Manufacturer Contact: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 50840555
• Report Number: 3012644426-2026-00007
• Device Sequence Number: 10461363
• Product Code: PUV
• UDI-Device Identifier: 15060391210015
• UDI-Public: 15060391210015
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: SMP02
• Device Catalogue Number: SMP02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown