Cook G26666Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00827002266667), received between Mar 27, 2018 and Sep 18, 2019 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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.

• MalfunctionSep 18, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

  Patient problems: No Patient Involvement

  MAUDE report 9082754 ↗
• MalfunctionJun 13, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8698382 ↗
• MalfunctionMar 27, 2018Device Operates Differently Than Expected; Packaging Problem; Device Operates Differently Than Expected; Packaging Problem

  IT WAS REPORTED THE ONE-STEP SUPRAPUBIC INTRODUCER HAD A PIN HOLE IN ITS UNOPENED ORIGINAL PACKAGING. THIS PACKAGING DEFECT WAS FOUND BY THE SURGERY INVENTORY COORDINATOR BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THIS REPORT IS ASSOCIATED WITH MEDWATCH 1820334-2018-00819.

  Patient problems: No Patient Involvement

  MAUDE report 7374547 ↗
• MalfunctionMar 27, 2018Device Operates Differently Than Expected; Packaging Problem; Device Operates Differently Than Expected; Packaging Problem

  IT WAS REPORTED THE ONE-STEP SUPRAPUBIC INTRODUCER HAD A PIN HOLE IN ITS UNOPENED ORIGINAL PACKAGING. THIS PACKAGING DEFECT WAS FOUND BY THE SURGERY INVENTORY COORDINATOR BEFORE USE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT. THIS REPORT IS ASSOCIATED WITH MEDWATCH 1820334-2018-00820.

  Patient problems: No Patient Involvement

  MAUDE report 7374201 ↗