Cook G46218Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00827002462182), received between Aug 7, 2017 and Apr 16, 2019 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2019Break; Break

  IT WAS INITIALLY REPORTED, DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR (TURBT) USING STORZ RESECTOSCOPE, THE COOK CUTTING LOOP BECAME LOOSE BUT NOT DETACHED DURING THE PROCEDURE. NO HARM TO PATIENT. OPENED ANOTHER CUTTING LOOP AND FINISHED PROCEDURE. THE DEVICE FAILURE ANALYSIS PERFORMED BY THE MANUFACTURER ON 01APR2019, FOUND THE RETURNED CUTTING LOOP WAS BROKEN, NOT LOOSE AS WAS INITIALLY REPORTED. AS REPORTED, NO UNINTENDED SECTION OF THE DEVICE REMAINED INSIDE THE PATIENT'S BODY. NO ADDITIONAL PROCEDURES WERE REQUIRED AND THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520936 ↗
• MalfunctionNov 29, 2018Fracture

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116156 ↗
• MalfunctionNov 28, 2018Break

  IT WAS REPORTED THAT DURING THE RESECTION PORTION OF THE PROCEDURE, THE CUTTING LOOP BROKE IN THREE INSTANCES. THERE WERE NO ADVERSE EFFECTS REPORTED DUE TO THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112444 ↗
• InjuryAug 8, 2017Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER REPORTED DURING A HYSTEROSCOPY PROCEDURE WHILE USING THE COOK CUTTING LOOP, THE RESECTOSCOPE LOOP BROKE OFF IN THE PATIENT. THE BROKEN PORTION WAS RETRIEVED FROM THE PATIENT WITHOUT CONSEQUENCE. A SECOND COOK CUTTING LOOP WAS USED. THE SECOND RESECTOSCOPE LOOP BROKE OFF BUT IT COULD NOT BE FOUND. AS REPORTED, THESE ISSUES CONTRIBUTED TO AN EXTENDED TIME IN SURGERY. THE LENGTH OF TIME THE SURGERY WAS EXTENDED HAS NOT BEEN PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THESE ISSUES. THIS REPORT IS BEING FILED TO CAPTURE THE REPORTED FIRST LOOP BREAKAGE. THE SECOND LOOP BREAKAGE CAN BE FOUND IN MEDWATCH REPORT NUMBER 1820334-2017-02296.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6773276 ↗
• InjuryAug 7, 2017Break; Material Fragmentation; Break; Material Fragmentation

  THE CUSTOMER REPORTED DURING A HYSTEROSCOPY PROCEDURE WHILE USING THE COOK CUTTING LOOP, THE RESECTOSCOPE LOOP BROKE OFF IN THE PATIENT. THE BROKEN PORTION WAS RETRIEVED FROM THE PATIENT WITHOUT CONSEQUENCE. A SECOND COOK CUTTING LOOP WAS USED. THE SECOND RESECTOSCOPE LOOP BROKE OFF BUT IT COULD NOT BE FOUND. AS REPORTED, THESE ISSUES CONTRIBUTED TO AN EXTENDED TIME IN SURGERY. THE LENGTH OF TIME THE SURGERY WAS EXTENDED HAS NOT BEEN PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS AS A RESULT OF THESE ISSUES. THIS REPORT IS BEING FILED TO CAPTURE THE SECOND LOOP BREAKAGE ISSUE. THE FIRST LOOP BREAKAGE REPORT CAN BE FOUND IN MEDWATCH REPORT NUMBER 1820334-2017-02159.

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 6772678 ↗