PHASTIPP RESECTOR HANDPIECE
Received Jul 3, 2024 · Event occurred Jun 7, 2024
Report 1220948-2024-00128 · MDR key 19665995
Device
Product problems
- Device Contamination with Body Fluid
- Device Contamination with Body Fluid
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, THE PROVIDED PHOTO CONFIRMED THE REPORT. MANUFACTURING ATTEMPTED TO RECREATE THE ISSUE WHILE TESTING, BUT WAS UNABLE TO REPRODUCE THE FAILURE FOR 3 DIFFERENT LOTS OF FINISHED GOODS. IT IS LIKELY THAT THE ISSUE IS DUE TO THE USE/SETUP AT THE SITE. HOWEVER, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THEREFORE, WE'RE UNABLE TO PERFORM A LOT REVIEW.
Description of Event or Problem
IT WAS REPORTED THAT BLOOD IS CONTINUOUSLY GETTING TRAPPED IN THE PHASTIPP RECTOR HANDPIECE. THE STAFF HAS BEEN USING PEROXIDE TO CLEAN WITH A Q-TIP. NO INJURY WAS REPORTED TO THE PATIENT.