AIR/WATER VALVE MAJ-1444 (UDI 04953170209680)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170209680), received between Jan 5, 2023 and Jun 18, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Clean Adequately” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 18, 2024Device Contamination with Body Fluid; Failure to Clean Adequately; Device Contamination with Body Fluid; Failure to Clean Adequately

  IT WAS REPORTED THAT THE AIR/WATER VALVE WAS USED IN A CASE WITH HEAVY BLEEDING, THOROUGHLY CLEANED WITH THE ENDOSCOPE REPROCESSOR, AND STORED. THE NEXT DAY, BEFORE A PROCEDURE, BLOOD WAS NOTICED DRIPPING FROM THE AIR/WATER NOZZLE OF THE GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE FOR AN UNSPECIFIED PROCEDURE WHICH WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559401 ↗
• MalfunctionJun 18, 2024Device Contamination with Body Fluid; Failure to Clean Adequately; Device Contamination with Body Fluid; Failure to Clean Adequately

  IT WAS REPORTED THAT THE AIR/WATER VALVE WAS USED IN A CASE WITH HEAVY BLEEDING, THOROUGHLY CLEANED WITH THE ENDOSCOPE REPROCESSOR, AND STORED. THE NEXT DAY, BEFORE A PROCEDURE, BLOOD WAS NOTICED DRIPPING FROM THE AIR/WATER NOZZLE OF THE GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE FOR AN UNSPECIFIED PROCEDURE WHICH WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19559377 ↗
• MalfunctionJun 17, 2024Device Contamination with Body Fluid; Failure to Clean Adequately; Device Contamination with Body Fluid; Failure to Clean Adequately

  IT WAS REPORTED THAT THE AIR/WATER VALVE WAS USED IN A CASE WITH HEAVY BLEEDING, THOROUGHLY CLEANED WITH THE ENDOSCOPE RE-PROCESSOR, AND STORED. THE NEXT DAY, BEFORE A PROCEDURE, BLOOD WAS NOTICED DRIPPING FROM THE AIR/WATER NOZZLE OF THE GASTROVIDEOSCOPE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE INSPECTION FOR AN UNSPECIFIED PROCEDURE WHICH WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547899 ↗
• MalfunctionJun 13, 2024Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT WHEN THE AIR/WATER VALVE WAS USED WITH THE GF-UCT260, BLOOD STARTED DRIPPING FROM THE AIR/WATER NOZZLE. THE ISSUE OCCURRED DURING PREPARATION BEFORE USE INSPECTION FOR AN UNSPECIFIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER SIMILAR DEVICE. THERE WERE NO REPORTS OF DELAYS. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533359 ↗
• MalfunctionJun 4, 2024Break; Break

  IT WAS REPORTED, DURING REPROCESSING, A PIECE OF BROKEN PACKING FROM THE AIR/WATER VALVE FLOATED OUT OF THE WATER. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19461787 ↗
• MalfunctionJan 5, 2023Device Reprocessing Problem; Failure to Clean Adequately; Device Reprocessing Problem; Failure to Clean Adequately

  IT WAS REPORTED DIRT OBSERVED COMING OUT FROM THE TIP OF THE SCOPE GF-UCT260, STRING OF BLOOD WAS OBSERVED. THE USE OF DEVICE WAS IMMEDIATELY DISCONTINUED AND WAS NOT USED ON ANOTHER PATIENT. ACCORDING TO THE REPORT, THE DEVICE WAS CLEANED USING AN OER-5 (SCOPE REPROCESSOR MACHINE) AFTER ITS USES ON 12/2 AND IN THE MORNING OF 12/6, THE REPORTED EVENT OCCURRED. THERE WAS NO HARM REPORTED. . NO PATIENT HARM, NO USER INJURY REPORTED AS THE RESULT OF THE EVENT. THERE IS NO PATIENT INFECTION ASSOCIATED ON THIS REPORTED EVENT. THE SCOPE ON THE EVENT REPORTED WAS USED IN COMBINATION WITH MAJ-1444 DEVICE (AIR/WATER VALVE UNIT). THIS REPORT IS BEING SUBMITTED FOR THE MAJ-1444 DEVICE (AIR/WATER VALVE UNIT)- REPORT WITH PATIENT IDENTIFIER (B)(6). THIS EVENT INCLUDES TWO REPORTS : REPORT WITH PATIENT IDENTIFIER (B)(6) (MAJ-1444). REPORT WITH PATIENT IDENTIFIER (B)(6) ( SCOPE GF-UCT260, SN (B)(4)). THIS REPORT IS FOR REPORT WITH PATIENT IDENTIFIER (B)(6) (MAJ-1444).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16100704 ↗