Cook G03196Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002031968), received between Apr 6, 2017 and Oct 10, 2017 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 10, 2017Break

  IT WAS REPORTED THAT DURING THE PATIENT'S CHOLANGIOGRAPHY, APPROXIMATELY 5 CM OF THE END OF THE 5 FR CATHETER "SHEARED" OFF WHEN REMOVING FROM THE TUOHY NEEDLE. PER THE MANUFACTURER'S REPRESENTATIVE, "I BELIEVE THE EVENT OCCURRED OUTSIDE THE PATIENT AND I WAS ADVISED THAT THERE WAS NO IMPACT ON THE PATIENT". NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6935321 ↗
• MalfunctionApr 6, 2017Material Separation; Sticking; Structural Problem; Physical Resistance; Material Separation; Sticking; Structural Problem; Physical Resistance

  INTERNATIONAL CUSTOMER REPORTED THAT A COOK ENDOSCOPIC CHOLANGIOGRAPHY SET WAS PROVIDED TO A SURGEON FOR TRIAL. THE SURGEON COMMENTED THAT THE 5 FR CATHETER WAS A TIGHT FIT INTO THE NEEDLE. THE SURGEON COMPLETED THE PROCEDURE WITHOUT ANY INCIDENTS OR COMPLICATIONS. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE SURGEON THEN OPINED THAT THERE EXISTS A STRONG RISK THAT THE DISTAL END OF THE CATHETER COULD BE CUT OR SLICED OFF BY THE NEEDLE WHEN THE CATHETER IS EXTRACTED AFTER IT WAS FULLY ENGAGED AND PASSED THE DISTAL END OF THE NEEDLE. THE SURGEON DEMONSTRATED THIS CONCERN TO THE SALES REPRESENTATIVE. THERE WAS NO PATIENT INVOLVEMENT AT THE TIME OF THIS DEMONSTRATION, ACCORDINGLY THERE IS NO REPORTED ADVERSE PATIENT CONSEQUENCE ASSOCIATED WITH THIS POTENTIAL MALFUNCTION. THE DEVICE IS REPORTEDLY AVAILABLE FOR EXAMINATION. THE DEVICE HAS NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 6463419 ↗