Cook G17359Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002173590), received between Aug 16, 2018 and Dec 2, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2024Material 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 20820466 ↗
• MalfunctionNov 19, 2021Material Separation; Material Separation

  AS REPORTED, THE TIP OF A SELECTIVE SALPINGOGRAPHY CATHETER WAS FOUND TO BE BROKEN WHEN REMOVING THE DEVICE FROM THE PACKAGING. A PHOTO OF THE DEVICE APPEARS TO SHOW THE TIP PARTIALLY SEPARATED. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12842767 ↗
• MalfunctionMar 18, 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 11520129 ↗
• MalfunctionAug 16, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A HYDROTUBATION, THE OPERATOR INSERTED THE SELECTIVE SALPINGOGRAPHY CATHETER INTO THE 22° HYSTEROSCOPE BY HAND. THE CATHETER COULD NOT MOVE FORWARD AFTER IT WAS INSERTED ABOUT 2 CENTIMETERS (CM). THE OPERATOR WITHDREW THE CATHETER AND FOUND THE END TIP OF THE CATHETER WAS BROKEN OFF. REQUESTS WERE MADE FOR ADDITIONAL INFORMATION REGARDING FURTHER DETAILS OF THE EVENT, HOWEVER, THE CUSTOMER HAS NOT PROVIDED ANY FURTHER INFORMATION. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7790079 ↗