Porges Coloplast AXXL10Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03600040277508), received between Feb 27, 2017 and May 2, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  ACCORDING TO THE AVAILABLE INFORMATION, THE SLIT IN THE SIDE OF THE DEVICE DID NOT APPEAR FLUSH WITH THE SHAFT. THE SURGEON FELT THAT IT COULD BE TRAUMATIZING TO THE URETER AND DID NOT WANT TO USE IT. A NEW DEVICE WAS OPENED AND THE CASE WAS COMPLETED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16857535 ↗
• InjuryAug 1, 2017Migration or Expulsion of Device; Positioning Problem

  ACCORDING TO THE AVAILABLE INFORMATION, OPENING OF THE MANDREL IN ITS DISTAL PART CAUSING AN EXIT OF THE GUIDE DURING INSERTION - THE CLINICAL CONSEQUENCES FOR THE PATIENT: LESION OF THE URETER REQUIRING A NIGHT OF HOSPITALIZATION WHILE THE PATIENT WAS EXPECTED IN AMBULATORY.

  Patient problems: Injury

  MAUDE report 6757696 ↗
• MalfunctionFeb 27, 2017Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE AVAILABLE INFORMATION, EVENT OCCURRED DURING THE EXTRACTION OF A STONE WITH DORMIA; THEY REMOVED DORMIA AND THEY SAW THE PIECE OF THE SHEATH LIKE A THREAD WITH THE URETEROSCOPE -THEY USED AN OLYMPUS V2, OBJECT OF A FSN - (SEE (B)(4) 9610711-2017-00006).

  Patient problems: Foreign Body In Patient

  MAUDE report 6360859 ↗
• MalfunctionFeb 27, 2017Crack

  ACCORDING TO THE AVAILABLE INFORMATION, DURING THE EXTRACTION OF A STONE OF LESS THAN 2 MM WITH DORMIA, THEY NOTICED THAT THE ACCESS SHEATH CRACKS AND THAT PIECES OF PLASTIC REMOVE AT THE SAME TIME. SEVERAL PLASTIC WIRES ARE THEN RECOVERED WHICH HAVE BEEN FLUSHED TOWARDS THE KIDNEY. CONSEQUENCES: OBLIGATION OF WITHDRAWAL OF THE PLASTIC WIRES. EXTENSION OF THE SURGICAL TIME WITH SKEPTICAL RISK IF FORGETFUL OF FILAMENTS DESPITE CAREFUL CONTROL WITH THE URETEROSCOPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6360853 ↗