COOK G23646Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002236462), received between Jul 31, 2017 and Jan 3, 2020 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2020Material Fragmentation; Material Fragmentation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DURING THE TIME OF INSERTION WITH THE HELP OF LARYNGOSCOPE THE DISTAL END WAS FRACTURED. FRACTURED NEAR THE TIP AND THEN PROCEDURE WAS COMPLETED IN CONVENTIONAL WAY OF INTUBATION. PATIENT OUTCOME: THE PRODUCT DID CAUSE/CONTRIBUTE TO THE NEED FOR ADDITIONAL PROCEDURE: CONVENTIONAL ENDOTRACHEAL INTUBATION. PLEASE SPECIFY ADVERSE EFFECT(S) AND PROVIDE DETAILS: DELAY IN THE TIME FOR SECURING AIRWAY.

  Patient problems: No Information

  MAUDE report 9543534 ↗
• InjuryDec 11, 2019Material Fragmentation; Material Fragmentation

  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 9449298 ↗
• InjurySep 16, 2019Material Fragmentation; Material Fragmentation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9068919 ↗
• MalfunctionJul 18, 2019Material Fragmentation; Material Fragmentation

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

  Patient problems: No Information

  MAUDE report 8801658 ↗
• InjuryApr 30, 2019Material Fragmentation; Material Fragmentation

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8564008 ↗
• InjuryJan 28, 2019Material Fragmentation; Material Fragmentation

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PRODUCT USED FOR DIFFICULT INTUBATION. AFTER USING THE FROVA STYLET, FOR THE POSITIONING OF THE DUAL ADAPTOR, A BRONCHOSCOPY WAS PERFORMED AND A PIECE OF THE BLUE COVER OF THE SHEATH WAS ALSO SUCKED. ADDITIONAL INFORMATION RECEIVED FROM REP. 03JAN2019: I CALLED THE CHIEF PRIMARY AND BOTH WERE USED IN THORACIC SURGERY AND FOR SURE ONE OF THEM WAS USED WITH DLT. ADDITIONAL INFORMATION RECEIVED 14JAN2019 FROM TRANSLATED DOCUMENT: DEVICE USED FOR DIFFICULT INTUBATION. AFTER USING THE FROVA MANDREL TO POSITION THE DOUBLE-LUMEN TUBE, A BRONCHOSCOPY WAS CARRIED OUT DURING WHICH A SMALL PIECE OF THE BLUE SHEATH COVERING THE TUBE WAS ASPIRATED. PATIENT OUTCOME: NO INFORMATION.

  Patient problems: No Information

  MAUDE report 8280693 ↗
• MalfunctionApr 11, 2018Material Frayed; Material Frayed

  ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER 21APR2018: "THEIR REPLY WAS THAT THERE WAS NO ADVERSE EFFECT ON PATIENT DUE TO FROVA DAMAGE AND THEY DID NOT USED DOUBLE LUMEN ENDO TRACHEAL TUBE DURING THE PROCEDURE" PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 7420874 ↗
• MalfunctionJul 31, 2017Kinked; Kinked

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "2 TRIALS WITH VIDEOLARYNGOSCOPE AND FROVA WAS NOT SUCCESSFUL CAUSED OF KINKING. THE 3RD FROVA FROM A DIFFERENT CHARGE WAS THEN SUCCESSFUL". PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6753353 ↗
• MalfunctionJul 31, 2017Kinked; Kinked

  DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: "2 TRIALS WITH VIDEOLARYNGOSCOPE AND FROVA WAS NOT SUCCESSFUL CAUSED OF "KINKING". THE 3RD FROVA FROM A DIFFERENT CHARGE WAS THEN SUCCESSFUL". PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6753351 ↗