PHASTIPP RESECTOR HANDPIECE
Received Dec 13, 2024 · Event occurred Nov 14, 2024
Report 1220948-2024-00247 · MDR key 20924817
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 RECEIVED FOR INVESTIGATION. BLOOD WAS CONFIRMED IN THE RESECTOR HANDPIECE. MANUFACTURING ATTEMPTED TO RECREATE THE ISSUED 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. WE HAVE CONDUCTED A LOT OF HISTORY REVIEW AND DID NOT FIND ANY ISSUES NOTED IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS ISSUE. ALL QC TESTS PASSED THEIR REQUIREMENTS. WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF A SIMILAR NATURE FOR DEVICES FROM THIS LOT.
Description of Event or Problem
IT WAS REPORTED THAT BLOOD MADE IT INTO THE PHASTIPP RESECTOR. THE ISSUE WAS NOTICED AFTER A PROCEDURE, WHILE ATTEMPTING TO CLEAN IT FOR A FUTURE OPERATION. NO INJURY WAS REPORTED TO ANY PATIENT.