MalfunctionQAI
ELLACOR SYSTEM WITH MICRO-CORING TECHNOLOGY
Received Jun 1, 2023
Report 3020704367-2023-00013 · MDR key 17043074
Device
Generic name
Micro-coring Technology
Manufacturer
Cytrellis Biosystems, IncModel number
900-00024Catalog number
EL-HPC01
Product problems
- Loss of or Failure to Bond
- Break
- Material Integrity Problem
- Loss of or Failure to Bond
- Break
- Material Integrity Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
DURING THE REPAIR OF THE HANDPIECE, A BROKEN GLUE BOND WAS IDENTIFIED AND REPAIRED IN THE X/Y AXIS. THERE WERE NO COMPLAINTS FROM THE CUSTOMER ABOUT THIS HANDPIECE, AND NO REPORTS OF ANY ADVERSE EVENTS RELATED TO THIS DEVICE.
Description of Event or Problem
AS PART OF THE INVESTIGATION RELATED TO ANOTHER COMPLAINT AND MDR, ALL ELLACOR HANDPIECES IN THE FIELD WERE INSPECTED TO ENSURE THERE WERE NO POTENTIAL ISSUES WITH OTHER HANDPIECES. THIS HANDPIECE WAS FLAGGED AS REQUIRING SERVICE AND THE HANDPIECE WAS RETURNED TO CYTRELLIS FOR REPAIR.
Remedial action
- Replace
- Repair