Cook G14042Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002140424), received between Apr 12, 2018 and Apr 12, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Bent” (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.

• MalfunctionApr 12, 2018Bent; Fracture; Failure to Advance

  IT WAS REPORTED THAT THE PHYSICIANS USED THE ROUND TIP URETERAL CATHETER TO ENTER THE PEDIATRIC CYSTOSCOPE IN ORDER TO CHECK THE URETERAL ORIFICE. THE PHYSICIAN WAS UNABLE TO PUSH THE CATHETER FORWARD AS A RESULT OF ADVANCEMENT DIFFICULTY WHEN ENTERING THE CYSTOSCOPE. AFTER SEVERAL FAILED ATTEMPTS, THE PHYSICIAN REMOVED THE CATHETER AND NOTED THAT IT WAS BENT AND FRACTURED. IT WAS FURTHER NOTED THAT THE CATHETER WAS BENT BACKWARDS AND PARTIALLY SEVERED AT A SIDEPORT THAT WAS 3 CM (CENTIMETERS) FROM THE DISTAL TIP. THE PHYSICIAN EXPRESSED THAT THE CATHETER WAS TOO SOFT AND THE MATERIAL WAS NOT VERY GOOD. THIS PRODUCT PROBLEM REPORTEDLY OCCURRED PRIOR TO PATIENT CONTACT AND THERE WAS NO IMPACT TO THE PATIENT OR END USER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7426706 ↗