MalfunctionFAD
Biosoft duo double loop ureteral stent kit
Received May 7, 2026 · Event occurred Apr 17, 2026
Report 9610711-2026-00155 · MDR key 25111733
Device
Generic name
Urological Surgical Procedure Kit, Non-medicated, Single Use
Manufacturer
Coloplast A/sCatalog number
BCAG64
Lot number
10815471_BCAG644002
Product problems
- Break
- Device Handling Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE INVESTIGATION IS NOT YET COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED ON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
ACCORDING TO THE AVAILABLE INFORMATION, DURING THE PLACEMENT OF A STENT, THE PUSHER (INSERTION SYSTEM) BROKE DURING USE, RENDERING THE DEVICE UNUSABLE AND REQUIRING ITS IMMEDIATE REPLACEMENT ON TWO SEPARATE OCCASIONS FOR THE SAME PATIENT. A SECOND DEVICE WAS USED ON THE SAME PATIENT.