inforMED
MalfunctionIYO

NA

Received Dec 18, 2025 · Event occurred Oct 6, 2025

Report 23837430 · MDR key 23837430

Device

Generic name

System, Imaging, Pulsed Echo, Ultrasonic

Model number

IC5-9-D

Product problems

  • Device Reprocessing Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

STERILE PROCESSING IS CLEANING THEIR IC5-9D TRANSVAGINAL PROBES PER GE INSTRUCTIONS. THEY HAVE REQUIRED MANY REPAIRS ON THESE PROBES AND BIOMED/GE BELIEVE IT'S DUE TO OVERSATURATION OF FLUID. GE POINTS THEM TO ANOTHER PART OF THE MANUAL TO REFER TO FOR CLEANING THE PROBES, HOWEVER THE SPS [STERILE PROCESSING SERVICES] DEPARTMENT IS CLEANING THE SPECIFIC PROBE PER THE EXACT RECOMMENDATIONS. STERILE PROCESSING STATED THEY WILL NOT CHANGE THEIR PROCESS BECAUSE IT MATCHES THE MANUAL. THE HOSPITAL REQUESTED GE UPDATE THEIR MANUAL. LOCAL GE POINTS SPD TO PORTION OF MANUAL MARKED "EXAMPLE OF PROBE IMMERSION LEVEL", STERILE PROCESSING IS REFERRING TO THE PORTION OF MANUAL SPECIFICALLY NOTED AS PROBE IMMERSION LEVEL FOR IC5-9-D PROBES. AN UPDATE TO THE IFU IS NEEDED. MANUFACTURER RESPONSE FOR SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC, NA (PER SITE REPORTER). LOCAL GE POINTS SPD TO PORTION OF MANUAL MARKED "EXAMPLE OF PROBE IMMERSION LEVEL".