TRUNODE SURGICAL GAMMA PROBE
Received Jul 7, 2026 · Event occurred Mar 2, 2026
Report 1222780-2026-00423 · MDR key 25733047
Device
Generic name
Probe, Uptake, Nuclear
Manufacturer
Hologic, Inc.Model number
120-807605Catalog number
120-807605
Lot number
24D02RN
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
53 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A "LOCALIZED IDENTIFICATION BREAST LUMPECTOMY RIGHT AND A SENTINEL LYMPH NODE BIOPSY, AXILLA" SURGERY ON (B)(6) 2026 WITH THE TRUNODE GAMMA PROBE THAT " THE TRUNODE PROBE WAS MALFUNCTIONING DESPITE RESETTING THE TRUNODE TABLET. THE PROBE WAS READING FROM 1-999 INTERMITTENTLY." DUE TO THIS ISSUE, "THE TRUNODE PROBE WAS REMOVED FROM THE SURGICAL FIELD, AND A NEW PROBE WAS USED. NO PATIENT HARM." CUSTOMER OUTREACH WAS PERFORMED TO CLARIFY IF ANY ADDITIONAL MEDICAL OR SURGICAL INTERVENTIONS WERE REQUIRED, BUT THERE WAS NO RESPONSE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.