COOK G53517Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002535176), received between Mar 8, 2016 and Nov 22, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2019Difficult to Insert; Difficult to Insert

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9361486 ↗
• MalfunctionMar 8, 2016Device Operates Differently Than Expected

  DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE FROVA HAS A SIGNIFICANT BEND IN IT AND THE DOCTOR WAS UNABLE TO PASS THE ETT OVER THE FROVA TO INTUBATE THE PATIENT. THE FROVA HAD TO BE REMOVED AND ANOTHER BOUGIE PLACED TO BE ABLE TO INTUBATE PATIENT. PATIENT OUTCOME: NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE, BUT AN ADDITIONAL DEVICE HAD TO BE USED DURING THE PROCEDURE. NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5485397 ↗