AIR/WATER VALVE MAJ-1444 (UDI 04953170355929)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 04953170355929), received between Nov 29, 2021 and Oct 30, 2024 — classified as 2 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Contamination” (15 reports).

2 FDA recall records name this device's identifier, 2 still open.

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.

Recalls naming this device

1. Feb 12, 2026Class IIOpen, Classified

   The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.

   Z-1611-2026 · Root cause: Reprocessing Controls · Recall details · FDA record ↗

2. Jul 12, 2023Class IIOpen, Classified

   The air/water valve MAJ-1444 used with OER-Pro and OER-Elite may become damaged and result in loss of the one-way valve functionality by repeated automated endoscope reprocessing in Olympus OER machines, causing body fluid could backflow into the air/water channel of the ultrasonic endoscopes during the procedure.

   Z-2447-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE AIR/WATER VALVE WAS INSUFFICIENTLY /INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571562 ↗
• MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE AIR/WATER VALVE WAS INSUFFICIENTLY /INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571506 ↗
• MalfunctionOct 30, 2024Failure to Clean Adequately; Failure to Clean Adequately

  IT WAS REPORTED THAT THE AIR/WATER VALVE WAS INSUFFICIENTLY /INCORRECTLY REPROCESSED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20571385 ↗
• MalfunctionSep 6, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED, THAT THE AIR/WATER VALVE EXHIBITED A WATER LEAKAGE FROM THE BALLOON OF THE GASTROVIDEOSCOPE. AND THE AIR/WATER VALVE WAS REPLACED AND THE PROBLEM WAS RESOLVED. THE ISSUE WAS FOUND, DURING PREPARATION FOR USE. FOR AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20158488 ↗
• MalfunctionSep 15, 2023Lack of Maintenance Documentation or Guidelines; Lack of Maintenance Documentation or Guidelines

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE INSTRUCTION MANUAL FOR THE ULTRASONIC ENDOSCOPE HAS DESCRIPTION ABOUT THE INSPECTION OF THE AIR/WATER VALVE; HOWEVER, THERE WAS NO DESCRIPTION OF THE PASS/FAIL JUDGEMENT DUE TO WHICH IT WAS NOT POSSIBLE TO JUDGE THE EXTENT OF ALLOWABLE RANGE. THE CUSTOMER REQUESTED GUIDELINE FOR INSPECTION. THIS COMPLAINT IS BEING SUBMITTED TO CAPTURE THE ALLEGATION OF INSUFFICIENT INSPECTION GUIDELINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17754848 ↗
• MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 6 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623324 ↗
• MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 5 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623152 ↗
• MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 4 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623085 ↗
• MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 3 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623027 ↗
• MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 2 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), (B)(6), & (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622951 ↗
• MalfunctionAug 25, 2023Device Reprocessing Problem; Device Reprocessing Problem

  THE CUSTOMER REPORTED THAT WHILE HIS MEDICAL STAFF WAS WASHING AFTER AN EUS-FNA TEST, A THIN RED OBJECT CAME OUT FROM THE TIP OF HIS OLYMPUS AIR/WATER VALUE. REPORTEDLY, AFTER THAT, A RED-BROWN OBJECT APPEARED ALSO. AS THIS WAS DISCOVERED FOLLOWING THE COMPLETION OF THE PROCEDURE, THIS EVENT HAD NO IMPACT ON THE PATIENT OF THIS CASE. WHILE PERFORMING DILIGENCE CONCERNING THIS EVENT, IT BECAME CLEAR THAT THE USER FACILITY HAD BEEN INSUFFICIENTLY REPROCESSING SOME OF THEIR OLYMPUS DEVICES. THIS REPORT IS 1 OF 14 BEING SUBMITTED TO CAPTURE THE SERIES OF INSUFFICIENTLY REPROCESSED DEVICES BY THE SAME USER FACILITY. FOR THE RELATED FILES, PLEASE SEE REPORTS WITH PATIENT IDENTIFIERS: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622904 ↗
• MalfunctionFeb 3, 2023Use of Device Problem; Device Contamination with Body Fluid; Failure to Clean Adequately; Use of Device Problem; Device Contamination with Body Fluid; Failure to Clean Adequately

  ADDENDUM FEB 8, 2023: PRE-USE INSPECTION OF THE SCOPE WAS NOT CARRIED OUT PRIOR TO THE PROCEDURE. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE. THERE WAS A DELAY OF APPROXIMATELY FIVE MINUTES DUE TO DEVICE REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291897 ↗
• MalfunctionFeb 3, 2023Use of Device Problem; Use of Device Problem

  AS REPORTED BY THE CUSTOMER FOR THIS EVENT, AFTER USING THE SCOPE IN A DIAGNOSTIC ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE, THE BED-SIDE CLEANING WAS NOT IMMEDIATELY PERFORMED FOR THE SCOPE. THE SCOPE WAS NOT SOAKED IN DETERGENT SOLUTION, AND THE AIR/WATER NOZZLE WAS NOT FLUSHED WITH WATER AND AIR. FOR THE MANUAL CLEANING, THE AIR/WATER NOZZLE WAS NOT WIPED/BRUSHED WITH LINT-FREE GAUZE, BRUSH, OR SPONGE. THE AIR/WATER NOZZLE WAS FLUSHED WITH DETERGENT SOLUTION. NO INFORMATION PROVIDED ON ACCESSORIES USED FOR REPROCESSING. SUBSEQUENTLY, THREE DAYS LATER THE SCOPE WAS USED IN A DIAGNOSTIC ENDOSCOPIC ULTRASOUND (EUS) AND FOUND TO HAVE FAILED WITH AIR AND WATER SUPPLY. POST THE PROCEDURE, DURING REPROCESSING, IT WAS OBSERVED THAT A LARGE AMOUNT OF BLOOD CAME OUT OF THE AIR CHANNEL. THERE IS A POSSIBILITY THAT THIS BLOOD MAY HAVE BEEN IN THE SCOPE FROM THE REPROCESSING NOT PERFORMED CORRECTLY THREE DAYS PREVIOUSLY. THERE IS NO HARM REPORTED TO THE PATIENT OF THE PROCEDURE. FURTHER DUE DILIGENCE FOR THE EVENT, INCLUDING CURRENT STATUS OF THE PATIENT, IS BEING PERFORMED. THERE ARE TWO DEVICES INVOLVED IN THIS EVENT (AND TWO EVENTS THREE DAYS APART): ULTRASOUND GASTROVIDEOSCOPE AND ULTRASONIC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16291607 ↗
• InjurySep 12, 2022Restricted Flow rate; Restricted Flow rate

  THE CUSTOMER REPORTS DURING A LAPAROSCOPIC ULTRASOUND ENDOSCOPY PROCEDURE USING AN EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE WITH AN AIR/WATER VALVE FOR THE TREATMENT OF BLEEDING THERE WAS NO AIR SUPPLY AT ALL. THE PROCEDURE WAS ABORTED BECAUSE THERE WAS NO IMPROVEMENT AFTER WITHDRAWING THE SCOPE AND CHECKING IT. HEMOSTASIS WAS ACHEIVED THAT DAY USING ANOTHER SCOPE. THE NEXT DAY, THE PHYSICIAN STILL NEEDED THE ULTRASOUND FUNCTION, SO IT WAS DECIDED TO USE THE SCOPE AGAIN. ALTHOUGH THERE WERE NO ABNORMALITIES IN THE PRE-USE CHECK, AIR SUPPLY BECAME IMPOSSIBLE DURING THE PROCEDURE, AND IT WAS DECIDED TO CANCEL IT. FROM THE NEXT DAY ONWARDS, AFTER NEW EQUIPMENT ARRIVED, THE PROCEDURE WAS CARRIED OUT AND COMPLETED WITHOUT ANY PROBLEM. THERE IS NO IMPACT OR HEALTH HAZARD TO THE PATIENT RELATED TO STOPPING THE PROCEDURE DUE TO THE EQUIPMENT ISSUE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE FIRST PROCEDURE CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE AIR/WATER VALVE IN THE FIRST PROCEDURE CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE PROCEDURE THE FOLLOWING DAY. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE AIR/WATER VALVE USED IN THE PROCEDUR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402850 ↗
• InjurySep 12, 2022Restricted Flow rate; Restricted Flow rate

  THE CUSTOMER REPORTS DURING A LAPAROSCOPIC ULTRASOUND ENDOSCOPY PROCEDURE USING AN EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE WITH AN AIR/WATER VALVE FOR THE TREATMENT OF BLEEDING THERE WAS NO AIR SUPPLY AT ALL. THE PROCEDURE WAS ABORTED BECAUSE THERE WAS NO IMPROVEMENT AFTER WITHDRAWING THE SCOPE AND CHECKING IT. HEMOSTASIS WAS ACHIEVED THAT DAY USING ANOTHER SCOPE. THE NEXT DAY, THE PHYSICIAN STILL NEEDED THE ULTRASOUND FUNCTION, SO IT WAS DECIDED TO USE THE SCOPE AGAIN. ALTHOUGH THERE WERE NO ABNORMALITIES IN THE PRE-USE CHECK, AIR SUPPLY BECAME IMPOSSIBLE DURING THE PROCEDURE, AND IT WAS DECIDED TO CANCEL IT. FROM THE NEXT DAY ONWARDS, AFTER NEW EQUIPMENT ARRIVED, THE PROCEDURE WAS CARRIED OUT AND COMPLETED WITHOUT ANY PROBLEM. THERE IS NO IMPACT OR HEALTH HAZARD TO THE PATIENT RELATED TO STOPPING THE PROCEDURE DUE TO THE EQUIPMENT ISSUE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE FIRST PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE AIR/WATER VALVE IN THE FIRST PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE SCOPE USED IN THE PROCEDURE THE FOLLOWING DAY. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE AIR/WATER VALVE USED IN THE PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402784 ↗
• MalfunctionSep 5, 2022Material Deformation; Failure to Clean Adequately; Material Deformation; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE ENDOSCOPE (GF-UCT260) MADE IT IMPOSSIBLE TO SEND AIR. AFTER THE PROCEDURE, THE CUSTOMER CONFIRMED FOUND THAT A BLOOD CLOT WAS GENERATED FROM THE DUCT OF THE ENDOSCOPE. THE REPORTED PROBLEM WAS FOUND DURING PUNCTURE SUCTION METHOD UNDER ULTRASOUND ENDOSCOPY. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT WITHOUT ANY PROBLEMS BY CONTINUING THE PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THE CUSTOMER REPROCESSING THE DEVICE AS INSTRUCTED BY OLYMPUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15358908 ↗
• MalfunctionAug 2, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT BODY FLUID CAME OUT FROM THE TIP OF THE EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE THAT WAS USED WITH THE AIR/WATER VALVE AFTER THE SUCTION AND AIR SUPPLY WAS CHECKED. IN ADDITION, THE AIR/WATER SUPPLY BUTTON WAS DETERIORATED. THE EVENT OCCURRED DURING PREPARATION FOR USE AND THE SAME DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15153348 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120579 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120478 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120420 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120376 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120299 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120218 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120207 ↗
• MalfunctionJul 28, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT DURING REPROCESSING OF THE SUBJECT DEVICE FOLLOWING AN ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) PROCEDURE, A RED THREAD APPROXIMATELY TWENTY CENTIMETERS IN LENGTH CAME OUT FROM THE TIP OF THE DEVICE AFTER IT WAS WASHED. AFTER THE DEVICE WAS CLEANED A SECOND TIME, A PIECE APPROXIMATELY ONE CENTIMETER LONG CAME OUT OF THE DEVICE. TESTING OF THE SUBSTANCE THAT CAME OUT OF THE DEVICE FOUND IT WAS FIBRIN. THE USER NOTED THE AIR AND WATER SUPPLY WERE WEAK DURING THE PROCEDURE. THE USER ALSO STATED THE PRE-USE INSPECTION CONSISTED ONLY OF CHECKING BALLOON INFLATION. OTHER PRE-USE AND POST-USE INSPECTION WAS NOT PERFORMED. THE DEVICE WAS NOT CLEANED AT THE BEDSIDE FOLLOWING THE PROCEDURE. THE DEVICE WAS BROUGHT TO THE WASHROOM FOLLOWING THE PROCEDURE AND CLEANED IN THE SINK, BRUSHED, AND PUT IN THE WASHING MACHINE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR AN AIR/WATER VALVE THAT WAS IN USE AT THE FACILITY AT THE SAME TIME AS THE ENDOSCOPE. THE ENDOSCOPE IS BEING REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15120206 ↗