MalfunctionHCF
SUTURE PASSOR PRO¿, 150MM SUTURE PASSOR, ONE 10-12MM GUIDE AND TWO TROCAR SWABS
Received Apr 28, 2026
Report 3008254127-2026-00001 · MDR key 25024048
Device
Product problems
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
COMPLAINANT ALLEGES "THE SUTURE PASSER SNAPPED IN HALF TWICE, CAUSING INCREASED BLEEDING FOR THEIR PATIENTS. WHEN IT BREAKS, THE SURGEON MUST RETRIEVE A PORTION LEFT INSIDE THE PATIENT."
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE FOR EVALUATION. THE INVESTIGATION IS ONGOING. ONCE ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.