Cook G46210Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002462106), received between Oct 9, 2017 and Oct 9, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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 18, 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.

• MalfunctionOct 9, 2017Defective Component; Defective Component

  THE AREA REPRESENTATIVE REPORTED WHILE PREPARING TO USE THE COOK CUTTING LOOP, IT WAS NOTED THAT THE END THAT CONNECTS TO THE WORKING ELEMENT HAS A LARGER METAL PIECE TO IT. AS REPORTED, IT LOOKS LIKE A DEFECTIVE TIP AND IT WOULD NOT GO INTO THE SCOPE AT ALL. THIS DID NOT AFFECT THE PATIENT, THEY JUST OPENED ANOTHER ONE AND IT WAS NORMAL. NO UNINTENDED PORTION OF THE DEVICE WAS LEFT IN THE PATIENT¿S BODY. THERE WAS NO NEED FOR ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT. THERE WAS NO ADVERSE EFFECT OR CONSEQUENCE TO THE PATIENT DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED AT THE TIME OF THIS REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6929272 ↗