GE VOLUSON SB TRANSVAGINAL ULTRASOUND PROBE
Received Apr 17, 2025 · Event occurred Apr 1, 2025
Report MW5169248 · MDR key 21854413
Device
Generic name
System, Imaging, Pulsed Doppler, Ultrasonic
Manufacturer
Ge / Ge Healthcare Japan CorporationProduct problems
- Break
- Leak/Splash
- Structural Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
ON (B)(6) 2025, THE GE VOLUSON SB SERIAL NUMBER (B)(6) ULTRASOUND TRANSVAGINAL PROBE "BROKE IN HALF" AND ALL THE OIL SPILLED OUT ON THE FLOOR AND THE SHELF OF THE MACHINE. THE TECHNOLOGIST WAS TAKING THE HARD COVER OFF TO GET READY FOR A PATIENT. WHEN THE HARD COVER WAS REMOVED THE INSTRUMENT BROKE, NO BLUNT FORCE OR DROPPING OCCURRED. LUCKILY NO PATIENT WAS ON THE TABLE AT THE TIME AND EVEN MORE FORTUNATELY THE PROBE WAS NOT IN USE (INTERNAL ULTRASOUND PROBE). THE PROBE HAD NO VISIBLE DAMAGE AND NO CRACKS WHEN LAST USED THE DAY PRIOR. WHEN REVIEWED BY CLINICAL ENGINEERING, IT WAS NOTED THAT THE PROBE THAT BROKE WAS A REFURBISHED ONE. THE MACHINE HAD REGULAR PM'S LAST (B)(6) 2024. THE PROBE IS STORED IN A CLEAN BAG AND THEN A HARD COVER PROVIDED BY THE MANUFACTURER. OF NOTE, THE PHILIPS REPRESENTATIVE (WHO WE USE FOR CLINICAL ENGINEERING SERVICES) MENTIONED THAT THEY FEEL THE TROPHON IS THE PROBLEM, THAT THE HIGH HEAT OF THE TROPHON IS MAKING THE PROBES BRITTLE AND THAT THEY ARE SEEING THIS TYPE OF DAMAGE OCCUR MORE FREQUENTLY. IF HLD IS RECOMMENDED, THE PRODUCT SHOULD BE DESIGNED TO WITHSTAND THE TEMPERATURES NEEDED TO APPROPRIATELY CLEAN THE DEVICE.