DIGIT TRAP
Received Jun 18, 2026 · Event occurred Jun 2, 2026
Report 3007305485-2026-00133 · MDR key 25549548
Device
Product problems
- Unintended Movement
Patient
NA · Unknown
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
THIS COMPLAINT WAS CREATED DUE TO THE RECEIPT OF AN ANSM REPORT RECEIVED ON (B)(6) 2026 THE REPORT WAS WRITTEN AGAINST THE 9906, DIGIT TRAP FINGER GRASPING DEVICE. THE REPORT STATES THAT ON (B)(6) 2026, ¿REPEATED RELEASE OF TRACTION, OPERATIVE DIFFICULTY WITH INJURY OF THE RADIAL ARTERY DURING WRIST ARTHROSCOPY, CONVERSION OF THE SURGERY TO OPEN PROCEDURE TO ACHIEVE HEMOSTASIS.¿ FURTHER ASSESSMENT HAS BEEN SENT; HOWEVER, TO DATE NO NEW INFORMATION HAS BEEN RECEIVED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF CONVERTED TO AN OPEN PROCEDURE.
Additional Manufacturer Narrative
G3 INITIAL AWARENESS DATE WAS (B)(6) 2026. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION AND REVIEW. HOWEVER, THE COMPLAINT INVESTIGATION IS NOT COMPLETE AT THIS TIME. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE COMPLAINT INVESTIGATION. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.