Bander G16995Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002169951), received between Apr 5, 2017 and Apr 5, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2017Migration or Expulsion of Device; Material Separation; Migration or Expulsion of Device; Material Separation

  IT WAS REPORTED BY THE USER FACILITY THAT ON (B)(6) 2017, A MALE PATIENT UNDERWENT A ROBOTIC ASSISTED LAPAROSCOPIC CYSTOPROSTATECTOMY & ILIO CONDUIT CONVERSION CREATED. THE PATIENT WAS DISCHARGED TO GO HOME ONCE THE PROCEDURE WAS COMPLETE HOWEVER, ON (B)(6) 2017 THE PATIENT CALLED THE UROLOGIST TO INFORM THEM THAT THE STENT HAD FELL OUT. THE PATIENT HAD BROUGHT THE PART THAT FELL OUT BACK TO THE UROLOGIST AND NOTED THAT THE CURVED PART AT THE BOTTOM OF THE STENT WAS NOT ATTACHED. PER CT SCAN THE UROLOGIST CONFIRMED THE CURVED PART HAD RETAINED IN THE KIDNEY. A PROCEDURE WAS SCHEDULED ON AN UNKNOWN DATE IN (B)(6) TO REMOVE THE CURVED PART OF THE STENT AND WAS UNSUCCESSFUL WITH NO HARM TO THE PATIENT. THE UROLOGIST THEN WENT BACK IN ON (B)(6) 2017 TO DO AN ANTIGRADE ASSISTED RIGHT URETEROSCOPY WITH RETRIEVAL OF RETAINED RIGHT URETERAL STENT. THE UROLOGIST WAS SUCCESSFUL IN RETRIEVING THE STENT PORTION WITH NO HARM TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 6460058 ↗