Cook G46228Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002462281), received between Feb 16, 2016 and Nov 28, 2018 — classified as 2 injuries, 2 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 16, 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.

• MalfunctionNov 28, 2018Break; Device Damaged Prior to Use

  THE COMPLAINANT REPORTED THAT THE COOK CUTTING LOOP WAS BROKEN WHEN THE PACKAGE WAS OPENED. THIS PRODUCT PROBLEM WAS NOTED PRIOR TO USE, AND THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110283 ↗
• MalfunctionNov 9, 2017Material Fragmentation; Material Fragmentation

  THE AREA REPRESENTATIVE REPORTED A (B)(6) MALE PATIENT UNDERWENT A TRANSURETHRAL RESECTION OF THE PROSTATE (TURP). DURING THE PROCEDURE, WHILE USING THE COOK CUTTING LOOPS, THE LOOPS BROKE WHEN BEING PUT IN THE SCOPE. FIVE (5) SETS WERE OPENED TO COMPLETE THE PROCEDURE. NO UNINTENDED PORTION OF THE DEVICE WAS LEFT IN THE PATIENT¿S BODY AND THERE WAS NO NEED FOR ANY ADDITIONAL PROCEDURES DUE TO THIS EVENT. IT WAS NOT CLEAR AS TO WHETHER THERE WERE FOUR DEVICES THAT BROKE OR ONE DEVICE THAT BROKE AND FOUR ADDITIONAL DEVICES USED. NO INFORMATION RECEIVED AT THIS TIME FOR THE CLARIFICATION. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT DUE TO THESE OCCURRENCES. ON OCTOBER 30, 2017, VOLUNTARY MEDWATCH REPORT MW5072815 WAS RECEIVED FROM THE FDA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7012912 ↗
• InjuryJun 27, 2017Break; Break

  THE CUSTOMER REPORTED THAT THE COOK CUTTING LOOP MALFUNCTIONED DURING A TRANSCERVICAL RESECTION OF FIBROID PROCEDURE ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS ¿THE LOOP BROKE OFF INSIDE THE PATIENT¿S BODY¿. THE BROKEN LOOP WAS RETRIEVED FROM THE PATIENT¿S BODY. AS PER THE INITIAL REPORTER, NO SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT¿S BODY. THE PATIENT NEITHER REQUIRED ANY ADDITIONAL PROCEDURES NOR EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 6670247 ↗
• InjuryFeb 16, 2016Material Separation; Material Separation

  DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) ON THE PATIENT, THE LOOP BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS REMOVED FROM THE BLADDER VIA GRASPERS. PER INFORMATION PROVIDED BY THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 5437976 ↗