Cook G46211Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002462113), received between Jan 20, 2017 and Jul 24, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 16, 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.

• MalfunctionJul 24, 2018Material Separation; Material Separation

  IT WAS REPORTED, DURING A TRANS URETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE, THE LOOP OF THE COOK CUTTING LOOP BROKE OFF IN THE PATIENT'S BLADDER. AS REPORTED, THE PORTION OF THE BROKEN DEVICE WAS RETRIEVED FROM THE PATIENT. A SECOND COOK CUTTING LOOP WAS USED TO COMPLETE THE PROCEDURE WITHOUT DIFFICULTY. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714374 ↗
• MalfunctionJan 20, 2017Material Separation; Material Separation

  IT WAS REPORTED BY THE USER FACILITY THAT THE CUTTING WIRE CAME OFF IN THE RESECT-SCOPE LOOP. THE WIRE WAS RETRIEVED AND WAS ABLE TO BE REMOVED WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6265995 ↗