Cook G46209Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002462090), received between Nov 2, 2016 and Nov 29, 2018 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 29, 2018Break

  IT WAS REPORTED THAT TWO CUTTING LOOP WIRE WAS BROKEN INSIDE THE PATIENTS. ADDITIONAL INFORMATION WAS REQUESTED BUT NO RESPONSE WAS PROVIDED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient

  MAUDE report 8116564 ↗
• MalfunctionNov 29, 2018Break; Loose or Intermittent Connection

  IT WAS REPORTED DURING THE TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURPT) PROCEDURE, THE CUTTING LOOP WAS POSSIBLY LOOSEN OR BROKEN. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT AND NO REPORT OF AN ADDITIONAL PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8116153 ↗
• InjuryOct 13, 2017Material Fragmentation; Material Fragmentation

  THE AREA REPRESENTATIVE REPORTED, AN (B)(6) YEAR-OLD, MALE PATIENT WITH A PROSTATE TUMOR UNDERWENT A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). DURING THE PROCEDURE, WHILE A COOK CUTTING LOOP WAS BEING USED, THE MIDDLE OF THE CUTTING WIRE COMPLETELY BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE OF WIRE WAS RETRIEVED. THIS OCCURRED TWICE DURING USE OF TWO (2) COOK CUTTING LOOPS. 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.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6947244 ↗
• MalfunctionJun 20, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE COOK CUTTING LOOP MALFUNCTIONED DURING AN UNSPECIFIED PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE LOOP BROKE OFF INSIDE THE PATIENT¿S BODY. AS PER THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 6654069 ↗
• MalfunctionJun 13, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE COOK CUTTING LOOP MALFUNCTIONED DURING AN UNSPECIFIED PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE LOOP BROKE OFF INSIDE THE PATIENT¿S BODY. AS PER THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 6636179 ↗
• MalfunctionJun 13, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE COOK CUTTING LOOP MALFUNCTIONED DURING AN UNSPECIFIED PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE LOOP BROKE OFF INSIDE THE PATIENT¿S BODY. AS PER THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS REQUESTED REGARDING THE FAILURE OF THE DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 6636178 ↗
• InjuryNov 2, 2016Material Separation; Material Separation

  IT WAS REPORTED THE CUTTING LOOP DEVICE USED DURING A TRANSURETERAL RESECTION OF A BLADDER TUMOR BROKE OFF IN THE PATIENT AND WAS REMOVED WITH THE RIGID GRASPER. THE PHYSICIAN USED A THIRD DEVICE FROM A DIFFERENT LOT NUMBER TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT, NO ADDITIONAL PROCEDURES REQUIRED. THE PATIENT WAS DOING WELL POST PROCEDURE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6074172 ↗