SST EZ SPHERE - 20MM
Received Mar 30, 2026 · Event occurred Mar 4, 2026
Report 0008010177-2026-00046 · MDR key 24727397
Device
Product problems
- Device Difficult to Setup or Prepare
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE NEEDLES USED TO FIX THE MUSCLES IN PLACE COULD NOT BE INSERTED THROUGH THE DESIGNATED OPENINGS, AS THE OPENINGS WERE TOO NARROW AND THE SUTURE CHANNELS WERE NOT CONTINUOUS. THE SURGEON WAS REQUIRED TO APPLY SIGNIFICANT FORCE TO PENETRATE THE SPECIFIED SUTURE CHANNELS, WHICH RESULTED IN THE NEEDLE DEVIATING LATERALLY DURING THE PROCEDURE AND CAUSING AN INJURY TO THE SURGEON. NO SURGICAL DELAY OR ANY MEDICAL INTERVENTION WERE REPORTED AT INTAKE.
Additional Manufacturer Narrative
DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.