MAUDE Adverse Event Report: HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L. TRUNODE SURGICAL GAMMA PROBE; PROBE, UPTAKE, NUCLEAR

Model Number	120-807605
Health Effect - Clinical Codes	Breast Cancer (1759); Nodule (4551)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Over 60-year-old female with recent history of breast cancer.Procedure: left breast reflector localized lumpectomy with sentinel lymph node biopsy, possible axillary dissection.Trinode probe would not calibrate with unit.Another probe used successfully.No known harm to patient.Manufacturer response for probe, uptake, nuclear, trunode surgical gamma probe (per site reporter) will obtain.

• Brand Name: TRUNODE SURGICAL GAMMA PROBE
• Common Device Name: PROBE, UPTAKE, NUCLEAR
• Manufacturer (Section D): HOLOGIC SURGICAL PRODUCTS COSTA RICA, S.R.L.; 250 campus drive; marlborough MA 01752
• MDR Report Key: 20199440
• Report Number: 20199440
• Device Sequence Number: 6880262
• Product Code: IZD
• UDI-Device Identifier: 15420045512856
• UDI-Public: (01)15420045512856(17)260426(10)24D26R
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/21/2024
• Report Date (Section F): 08/21/2024

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: 24D26R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/12/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Date Report Sent to FDA: 08/21/2024