Cook G14043Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002140431), received between Oct 12, 2016 and Oct 12, 2016 — classified as 1 injury.

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

• InjuryOct 12, 2016Break; Break

  IT WAS REPORTED THAT AT THE END OF A URETERORENOSCOPY PROCEDURE, WHEN THE PHYSICIAN REMOVED THE CATHETER, IT WAS NOTED THE CATHETER HAD A PIECE OF THE LENGTH ¿CUT OFF¿ AND WAS INDWELL IN THE URETERAL OF THE PATIENT. A URETEROSCOPE AND FORCEPS WERE USED TO REMOVE THE FRAGMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6022104 ↗