Cook G46231Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00827002462311), received between Oct 27, 2016 and May 15, 2017 — classified as 1 injury, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2017Break; Material Separation; Break; Material Separation

  THE CUSTOMER REPORTED THAT THE COOK CUTTING LOOP MALFUNCTIONED DURING AN INTENDED TRANSURETHRAL PROSTATECTOMY ON A PATIENT. THE MALFUNCTION WAS DESCRIBED AS THE LOOP BROKE OFF FROM END OF THE WIRE AND DETACHED DUE TO EXCESSIVE TEMPERATURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 6567475 ↗
• InjuryOct 28, 2016Material Separation; Material Separation

  A MALE PATIENT OF UNKNOWN AGE UNDERWENT A TRANS URETHRAL RESECTION OF THE PROSTATE. THE UROLOGIST WAS RESECTING THE PROSTATE WITH THE CUTTING LOOP, WHEN THE CURVED CUTTING WIRE BECAME DETACHED FROM THE DEVICE. THE UROLOGIST HAD TO GO BACK IN WITH THE CYSTOSCOPE AND AN EXTRACTOR TO FIND THE PIECE OF WIRE IN THE PATIENT'S PROSTATE AND REMOVE IT. NO HARM WAS REPORTED TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6063071 ↗
• MalfunctionOct 27, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TRANSURETHRAL RESECTION OF PROSTATE (TURP) PROCEDURE. DURING THE PROCEDURE THE CUTTING WIRE BECAME DETACHED. THE UROLOGIST BEGAN WORKING ON RESECTING THE PROSTATE WITH THE LOOP, AT A SETTING OF 120/80¿WHICH IS A COMMON ENERGY SETTING FOR THIS PROCEDURE, ACCORDING TO THE TECH. AT SOME POINT A FEW MINUTES INTO THE CASE, THE PHYSICIAN REMOVED THE RESECTOSCOPE TO CLEAR TISSUE FROM THE LOOP, AND SAW THAT IT WAS NO LONGER THERE. THE ENTIRE LOOP SECTION OF WIRE HAD BURNED UP COMPLETELY AND DISINTEGRATED. HE OPENED ANOTHER LOOP, OF THE SAME LOT, AND IT BURNED UP AS WELL. BOTH LOOPS WILL BE RETURNED TO INVESTIGATIONS. THE CIRCULATING NURSE WENT TO GET ANOTHER LOOP WITH A DIFFERENT LOT NUMBER. THUS, ALLOWING THE SURGEON TO COMPLETE THE CASE. NOTHING WAS LEFT INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6060166 ↗