Cook G46213Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002462137), received between Mar 11, 2016 and Nov 29, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2018Break

  DURING A BLADDER TUMOR RESECTION PROCEDURE, THE COOK CUTTING LOOP BROKE OFF IN THE BLADDER. WITH IRRIGATION, THE DOCTOR WAS ABLE TO REMOVE THE LOOP FROM THE PATIENT. (SEE MFR# 1820334-2016-00146) ANOTHER DEVICE WAS USED FOR THE PROCEDURE, HOWEVER, WHEN THE DEVICE HAD BEEN REMOVED FROM THE SCOPE AND THE BLADDER HAD BEEN IRRIGATED, THE DOCTOR NOTED THAT ONE SIDE OF THE LOOP WAS BROKE BUT STILL ATTACHED (THIS MFR# 1820334-2018-03576). ANOTHER MANUFACTURERS DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8115499 ↗
• MalfunctionJun 15, 2016Break; Break

  THE LOOP BROKE SHORTLY AFTER STARTING THE CASE. THE LOOP DID NOT SEPARATE AND CAME OUT WHEN THE DEVICE WAS REMOVED. 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: No Known Impact Or Consequence To Patient

  MAUDE report 5726731 ↗
• MalfunctionMar 11, 2016Material Separation; Material Separation

  DURING A BLADDER TUMOR RESECTION PROCEDURE, THE COOK CUTTING LOOP BROKE OFF IN THE BLADDER. WITH IRRIGATION, THE DOCTOR WAS ABLE TO REMOVE THE LOOP FROM THE PATIENT. ANOTHER DEVICE WAS USED FOR THE PROCEDURE, HOWEVER, WHEN THE DEVICE HAD BEEN REMOVED FROM THE SCOPE AND THE BLADDER HAD BEEN IRRIGATED, THE DOCTOR NOTED THAT ONE SIDE OF THE LOOP WAS BROKE BUT STILL ATTACHED. ANOTHER MANUFACTURERS DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5495109 ↗