MAUDE Adverse Event Report: HOLOGIC, INC. TRUNODE SURGICAL GAMMA PROBE; PROBE, UPTAKE, NUCLEAR

Model Number	120-807605
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device history record (dhr) review was conducted for the reported lot number.The device was released meeting all qa specifications.
Event or Problem Description
It was reported that during a procedure on (b)(6) 2026, "the trunode gamma probe started malfunctioning.It would give me readings of 9999 randomly even when the probe was directed away from the primary injection site towards the wall.Also, the sentinel lymph node basin would give very low readings in the teens and twenties with no area of ¿hot¿ activity, which made identification of the sentinel lymph node impossible.I tried replacing the probe a couple of times, as well as replacing the associated trunode screen/monitor, without resolution of the issue." customer outreach was performed, but no further details are available at this time due to no response.Report stated the procedure was aborted.

• Brand Name: TRUNODE SURGICAL GAMMA PROBE
• Common Device Name: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer (Section G): HOLOGIC, INC.; 250 campus drive; marlborough MA 01752
• Manufacturer Contact: sarah lawlor ; 250 campus drive; marlborough, MA 01752
• MDR Report Key: 25460418
• Report Number: 1222780-2026-00350
• Device Sequence Number: 8708898
• Product Code: IZD
• UDI-Device Identifier: 15420045512856
• UDI-Public: (01)15420045512856(17)260704(10)24G04RP
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 07/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2026
• Device Model Number: 120-807605
• Device Catalogue Number: 120-807605
• Device Lot Number: 24G04RP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown