TRUNODE SURGICAL GAMMA PROBE
Received Jun 10, 2026 · Event occurred Feb 24, 2026
Report 1222780-2026-00350 · MDR key 25460418
Device
Generic name
Probe, Uptake, Nuclear
Manufacturer
Hologic, Inc.Model number
120-807605Catalog number
120-807605
Lot number
24G04RP
Product problems
- Communication or Transmission Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE REPORTED LOT NUMBER. THE DEVICE WAS RELEASED MEETING ALL QA SPECIFICATIONS.
Description of Event or Problem
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.