Cook G16193Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002161931), received between Apr 23, 2015 and Apr 23, 2015 — 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. How this data works · Data updated Oct 13, 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 23, 2015Material Separation

  THE DEVICE WAS USED FOR RETROGRADE PYELOGRAPHY WITH AN URETEROSCOPE INSERTED TRANSURETHRALLY. WHEN THE DEVICE WAS ADVANCED OVER A WIRE GUIDE PLACED IN THE URINARY BLADDER, THE PHYSICIAN CONFIRMED THAT AN UNKNOWN FOREIGN MATTER WAS FLOATING IN THE URINARY BLADDER. THE USER REMOVED THE DEVICE ONCE TO CHECK THE DEVICE TIP, THEN FOUND THAT THE CATHETER WAS FRACTURED AND PARTIALLY MISSING. FROM THE URETEROSCOPIC IMAGES, IT SEEMED THAT APPROXIMATELY 2MM OF THE CATHETER SEGMENT HAD SEPARATED. THE USER STOPPED USING THE DEVICE AND ANOTHER DEVICE WAS USED INSTEAD WITH NO PROBLEM. ALTHOUGH THE URETEROSCOPE WAS NOT INVESTIGATED AFTER THE EVENT, IT IS HIGHLY PROBABLE THAT THE SEGMENT HAD ALREADY BEEN EXPELLED NATURALLY WITH THE URINE IF IT WAS ONLY 2MM SIZE OF A FOREIGN MATTER. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED.

  Patient problems: Nonresorbable materials, unretrieved in body

  MAUDE report 4730799 ↗