Cook G14036Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002140363), received between Mar 30, 2016 and Mar 30, 2016 — 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.

• InjuryMar 30, 2016Material Separation; Material Separation

  DURING A RETROGRADE POLYGRAM PROCEDURE, WHEN THE CATHETER WAS BEING REMOVED, IT BROKE IN THREE PIECES. THE PHYSICIAN WAS ABLE TO REMOVE ALL OF THE PIECES. THE PHYSICIAN USED ANOTHER OF THE SAME DEVICE FROM A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. NO HARM TO THE PATIENT AND NO ADDITIONAL PROCEDURES OR INTERVENTION WAS REQUIRED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION RECEIVED ON 08MAR2016- THE CATHETER BROKE AT THE BEGINNING OF THE CASE AFTER IT WENT THROUGH THE CYSTOSCOPE. NO DYE HAD BEEN INJECTED THROUGH IT. THE PHYSICIAN PULLED THE REMNANTS OF THE CATHETER OUT WITH A FORCEP. (B)(6) 2016

  Patient problems: No Code Available

  MAUDE report 5534388 ↗