Cook G26908Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002269088), received between Mar 3, 2020 and Mar 3, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2020Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE ROADRUNNER PC WIRE GUIDE INCLUDED IN A COMMON BILE DUCT EXPLORATION SET STRIPPED AND BECAME DAMAGED DURING USE IN A LAPAROSCOPIC CHOLECYSTECTOMY WITH AN INTRAOPERATIVE CHOLANGIOGRAM AND COMMON BILE DUCT EXPLORATION. THE WIRE COULD HAVE BECOME STRIPPED UPON INTRODUCTION INTO THE WORKING CHANNEL OF THE URETEROSCOPE OR DURING MANIPULATION WITH THE LAPAROSCOPIC GRASPER USED IN THE PROCEDURE. THE DAMAGE OCCURRED UPON THE 4TH EXCHANGE. THE 1ST EXCHANGE WAS ADVANCING THE BALLOON DILATION CATHETER OVER THE WIRE, THE 2ND EXCHANGE WAS THE CHOLOEDOCHSCOPE OVER THE WIRE, THE 3RD EXCHANGE WAS ADVANCING THE BALLOON DILATION CATHETER OF THE WIRE, AND THE 4TH EXCHANGE WAS THE URETEROSCOPE OVER THE WIRE. THE SURGEON CONFIRMED THE WIRE GUIDE STRIPPED BUT NO PIECES CAME OFF OR WERE LEFT INSIDE THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9779787 ↗