Cook G46219Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002462199), received between Apr 11, 2016 and Nov 28, 2018 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2018Break

  IT WAS REPORTED THAT THE WIRE OF THE CUTTING LOOP BROKE PRIOR TO THE PROCEDURE. THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED, AND NO PARTS OF THE DEVICE WERE LEFT IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8112993 ↗
• MalfunctionNov 28, 2018Fracture; Device Damaged Prior to Use; Material Twisted/Bent

  IT WAS REPORTED THAT PRIOR TO THE USE OF COOK CUTTING LOOP, IT WAS NOTED THAT THE END OF THE CUTTING LOOP WAS FRACTURED. IT WAS FURTHER NOTED THAT THE LOOP ANGLE WAS BENT AGAINST MANUFACTURED SET ANGLE.

  Patient problems: No Patient Involvement

  MAUDE report 8111887 ↗
• MalfunctionNov 28, 2018Detachment of Device or Device Component

  THE COMPLAINANT REPORTED THAT THE METAL TIP OF THE COOK CUTTING LOOP (QUANTITY 3) CAME OFF INSIDE OF THE RESECTOSCOPE DURING A TRANSURETHRAL RESECTION OF BLADDER TUMOR. ANOTHER MANUFACTURER'S ELECTRODE WAS USED TO COMPLETE THE CASE. THIS PRODUCT PROBLEM OCCURRED PRIOR TO PATIENT CONTACT AS THE RESECTOSCOPE HAD NOT BEEN PLACED IN THE PATIENT. THEREFORE, IT DID NOT HAVE ANY REPORTED IMPACT ON THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110380 ↗
• MalfunctionNov 27, 2018Break; Entrapment of Device

  THE COMPLAINANT REPORTED THE FOLLOWING INFORMATION: AFTER USING A COOK CUTTING LOOP ON A PATIENT THEY NEEDED TO USE A ROLLER BALL. THE CUTTING LOOP WAS REMOVED AND THE ROLLER BALL COULD NOT BE INSTALLED. A ROLLER BALL FROM ANOTHER MANUFACTURER ALSO COULD NOT BE INSTALLED. AT THAT MOMENT IT WAS NOTED THAT THE PROXIMAL END OF THE STEM HAD SEVERED FROM THE STEM ITSELF AND REMAINED LODGED IN THE RESECTOSCOPE, PREVENTING THE INSTALLATION OF ANY ELECTRODE. THIS PRODUCT PROBLEM DID NOT RESULT IN ANY REPORTED SERIOUS INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8108879 ↗
• MalfunctionNov 12, 2018Break; Break

  IT WAS REPORTED, THE LOOP OF THE COOK CUTTING LOOP BROKE AFTER FIRST USE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THE ALLEGED MALFUNCTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE PATIENT AND THE EVENT. AT THE TIME OF THIS REPORT, NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8060705 ↗
• InjuryMar 21, 2017Break; Break

  IT WAS REPORTED BY THE USER FACILITY THAT A PATIENT UNDERWENT A PROSTATE PROCEDURE. THE COOK CUTTING LOOP WAS THE DEVICE IN USE. THE ATTENDING PHYSICIAN WAS ATTEMPTING TO REMOVE THE SCOPE FROM THE PATIENT WHEN HE REALIZED THE LOOP WAS BROKEN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECES OF THE LOOP BY HAND FROM THE PATIENT AND PROCEEDED TO COMPLETE THE SURGERY SUCCESSFULLY. AS A RESULT OF THIS EVENT, NO UNINTENDED SECTIONS OF THE DEVICE REMAINED INSIDE OF THE PATIENT¿S BODY, NOR DID THE PATIENT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6420281 ↗
• InjuryApr 11, 2016Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A TURP (TRANSURETHRAL RESECTION OF PROSTATE) PROCEDURE WAS BEING PERFORMED ON THE (B)(6) MALE PATIENT. THE PHYSICIAN CLAIMS THAT HE NEVER ACTIVATED ANOTHER MANUFACTURER'S CAUTERY DEVICE (NEVER STEPPED ON THE FOOT PEDAL) AND HE BELIEVES THAT THE DEVICE AUTOMATICALLY ACTIVATED. THE PHYSICIAN USED A CYSTOSCOPE TO LOOK. THEY REMOVED THE CYSTOSCOPE AND PLACED ANOTHER MANUFACTURER'S SCOPE INSIDE THE RESECTOSCOPE. THE PHYSICIAN WAS ADVANCING EVERYTHING DOWN WITH THE CUTTING LOOP INSIDE THE RESECTOSCOPE WHEN THEY NOTICED BUBBLES AND THAT THE SCOPE HAD A BAD PICTURE. THEY USED A DIFFERENT SCOPE AND CLEANED UP THE BUBBLES AND NOTICED A PERFORATION IN THE BLADDER. THE CASE BECAME AN OPEN CASE AND IT WAS DURING THIS TIME THE USER ALSO REALIZED THAT THE TIP HAD COME OFF THE CUTTING LOOP. THE TIP WAS RETRIEVED DURING THE TIME THE BLADDER WAS REPAIRED. IT IS ASSUMED THAT THE CUTTING LOOP CAUSED THE BLADDER PERFORATION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LONGER HOSPITAL STAY DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient; No Code Available; Perforation

  MAUDE report 5567628 ↗