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

Model Number	120-807605
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Disposable trunode handpiece ref:120-807605 not working.Handpiece turning on and talking to tablet but not picking up nuclear medicine over patient.Tried new tablet but had to change out handpiece.

• Brand Name: TRUNODE SURGICAL GAMMA PROBE
• Common Device Name: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): HOLOGIC, INC.; 445 simarano drive; marlborough MA 01752
• MDR Report Key: 22977081
• Report Number: 22977081
• Device Sequence Number: 21126425
• Product Code: IZD
• UDI-Device Identifier: 15420045512856
• UDI-Public: (01)15420045512856
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/18/2025
• Report Date (Section F): 07/18/2025

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: 120-807605
• Device Catalogue Number: 120-807605
• Device Lot Number: 25A23RC
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/05/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Sex: Female
• Date Report Sent to FDA: 07/18/2025