Cook G14818Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00827002148185), received between Apr 11, 2018 and Mar 13, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Separation” (6 reports).

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21597355 ↗
• MalfunctionJun 9, 2022Break; Break

  AS REPORTED, AN OPEN-END URETERAL CATHETER SEPARATED 4CM FROM THE DISTAL TIP BEFORE ENTERING THE PATIENT. ADDITIONAL PATIENT OUTCOME AND EVENT INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 14645504 ↗
• MalfunctionMay 3, 2021Material Separation; Material Separation

  THE INFORMATION REPORTED IN THE INITIAL REPORT WAS NOTED TO HAVE OCCURRED DURING THE SAME CASE WITH THE SAME LOT AS REPORTED IN PATIENT REFERENCE (B)(6) (MDR REPORT REFERENCE NUMBER 1820334-2021-01268).

  Patient problems: Insufficient Information

  MAUDE report 11759494 ↗
• InjuryMay 3, 2021Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED ON 27APR2021. THE PROCEDURE WAS A RIGID URETEROSCOPY. FOLLOWING THE DEVICE SEPARATION, A PORTION OF THE DEVICE WAS STUCK, AND ALLIGATOR FORCEPS WERE USED TO REMOVE IT WITH DIFFICULTY. THE ORIGINAL PROCEDURE WAS STOPPED, A DOUBLE J STENT WAS PLACED, TAKING ABOUT 20-30 MINUTES, AND THE REMAINDER OF THE PROCEDURE WAS POSTPONED. THERE WAS A POSSIBLE FALSE PASSAGE IN THE URETER. IT HAS BEEN NOTED THAT ALL UNINTENDED PIECES OF THE DEVICE WERE REMOVED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 11759492 ↗
• MalfunctionApr 28, 2021Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739043 ↗
• MalfunctionNov 17, 2020Material Separation; Material Separation

  AS REPORTED, DURING A URETERAL CATHETERIZATION PROCEDURE USING AN OPEN-END URETERAL CATHETER, THE CATHETER "RUPTURED". A PHOTO PROVIDED BY THE CUSTOMER APPEARS TO SHOW A SECTION OF THE CATHETER HAS SEPARATED. THE USER REPLACED THE DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10851955 ↗
• MalfunctionMay 1, 2020Material Separation; Material Separation

  IT WAS REPORTED, DURING AN UNKNOWN PROCEDURE, THE TIP OF AN OPEN-END URETERAL CATHETER SHEARED OFF INSIDE THE PATIENT. THE INSERTED END OF THE CATHETER THAT HAD BROKEN OFF WAS APPROXIMATELY 10 CM. AN NGAGE STONE EXTRACTOR WAS USED TO RETRIEVE THE SECTION OF CATHETER THAT HAD BROKEN OFF AND THE PROCEDURE WAS COMPLETED. NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10016871 ↗
• MalfunctionApr 6, 2020Material Fragmentation; Material Fragmentation

  ADDITIONAL INFORMATION PROVIDED ON 01APR2020: A STANDARD DOUBLE J INDWELLING URETERAL STENT WAS PLACED AS PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9928108 ↗
• MalfunctionFeb 7, 2020Crack; Crack

  IT WAS REPORTED, DURING A CYSTOSCOPY PROCEDURE, AN OPEN-END URETERAL CATHETER WAS USED TO OBTAIN ACCESS INTO A URETER. WHEN THE CATHETER WAS REMOVED, A KINK AND CRACK IN THE CATHETER WAS NOTICED. WHEN EXAMINING THE CATHETER, IT WAS ALMOST COMPLETELY BROKEN AND THEN BROKE COMPLETELY SHORTLY AFTER. THERE WAS NO AFFECT ON THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9680769 ↗
• MalfunctionOct 9, 2019Break; Break

  NO NEW PATIENT OR EVENT INFORMATION SINCE LAST REPORT WAS SUBMITTED ON (B)(6) 2019.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9172111 ↗
• MalfunctionMar 13, 2019Break; Break

  IT IS REPORTED DURING A CYSTOSCOPY WITH RETROGRADES USING A 6FR PEDIATRIC CYSTOSCOPE AND A COOK OPEN-END URETERAL CATHETER, SEVERAL PIECES OF THE URETERAL CATHETER BROKE OFF IN THE BLADDER. THE SURGEON WAS ABLE TO RETRIEVE ALL OF THE PIECES DURING THE SAME PROCEDURE USING GRASPERS. AFTER REMOVING THE PIECES, THE SURGEON PLACED A WIRE GUIDE, THEN PLACED A 4FR STENT WITH FLUORO AND INJECTED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED NO ADVERSE EFFECTS AS A RESULT OF THIS ALLEGED PRODUCT MALFUNCTION. ADDITIONAL PATIENT SPECIFIC DETAILS WERE REQUESTED, HOWEVER THE COMPLAINT FACILITY STATED THAT THEY COULD NOT RELEASE PATIENT SPECIFIC INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8417510 ↗
• MalfunctionJun 21, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A RETROGRADE PYELOGRAM / CATHETER INSERTION PROCEDURE THAT THE OPEN-END URETERAL CATHETER WAS INSERTED FOR USE, AND PART OF URETERAL CATHETER DISINTEGRATED AND WAS SPOTTED IN LEFT URETERAL ORIFICE (UO). THIS PART WAS THEN RETRIEVED FROM THE PATIENT. THE CASE, AS REPORTED, WAS A 3 STAGE SURGERY THAT STARTED OFF WITH A RIGID CYSTOSCOPY FIRST. A URETERIC CATHETER WAS INSERTED BY THE DOCTOR RETROGRADE FOR A PYELOGRAM, SOON AFTER THERE WAS AN UNIDENTIFIED GREEN STRING-LIKE OBJECT WITH BLACK SPOTS DANGLING FROM THE UO SPOTTED ON THE CAMERA SCREEN. THE DOCTOR AND HER ASSISTANT WERE NOTIFIED AND ASKED FOR A GRASPER TO RETRIEVE THE OBJECT AND IT WAS REMOVED. UPON TAKING OUT THE URETERAL CATHETER IT WAS FOUND THAT PART OF THE OUTER SIDE OF THE URETERAL CATHETER HAD DISINTEGRATED. SURGEONS DID A VISUAL INSPECTION WITH RIGID CYSTOSCOPE. IT WAS FURTHER REPORTED THAT THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED. IT WAS FURTHER CLARIFIED THAT THE INSERTION WAS EASY AND WHILE DOING THE PYELOGRAM AND PUSHING THE SHEATH UP IT WAS NOTED THAT THE "SHEATH" WAS COMING OFF. ONCE THE CATHETER WAS REMOVED THE DISLODGED PIECE WAS REMOVED WITH FORCEPS. IT WAS FURTHER STATES THA

  Patient problems: Foreign Body In Patient

  MAUDE report 7627732 ↗
• MalfunctionApr 12, 2018Break

  THE COMPLAINANT REPORTED THAT THE SURGEON WAS ATTEMPTING TO THREAD THE CATHETER (OPEN-END URETERAL CATHETER) ON THE WIRE, AND THE CATHETER BROKE INTO TWO PIECES. THE CATHETER WAS NOT IN THE PATIENT WHEN THIS PRODUCT PROBLEM OCCURRED, AND THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7427179 ↗
• MalfunctionApr 11, 2018Break

  THE COMPLAINANT REPORTED THAT THE OPEN-END URETERAL CATHETER BROKE IN TWO WHILE THE SURGEON WAS USING IT DURING A CYSTO +1/0 PROCEDURE. THE CATHETER SNAPPED AS THE SCOPE WAS BEING WITHDRAWN OVER IT AND NO EXTRA FORCE WAS BEING APPLIED COMPARED TO USUAL. THE PATIENT WAS A BABY/SMALL CHILD AND THE CATHETER BROKE OUTSIDE OF THE PATIENT., SO THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7421729 ↗