SINGLE USE SUCTION VALVE MAJ-209Recalls & reported problems
Olympus Medical Systems Corp. · SINGLE USE SUCTION VALVE MAJ-209 · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Olympus single-use suction valve is used with endoscopes. The 228 reports mostly describe the valve breaking or snapping off, with a few describing parts detaching. The reports include 4 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 228
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 228 adverse event reports that list this exact device (DI 14953170152426), received between Mar 22, 2019 and Dec 8, 2025 — classified as 4 injuries, 224 malfunctions.
The most frequently reported specific device problem is “Break” (213 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.
Reports received per month
Most reported problems
Device problems
- Break213
- Detachment of Device or Device Component5
- Device Reprocessing Problem3
- Adverse Event Without Identified Device or Use Problem1
- Contamination1
- Device Contaminated During Manufacture or Shipping1
- Device Damaged Prior to Receipt by User1
- Device Handling Problem1
Patient problems
- No Consequences Or Impact To Patient205
- No Clinical Signs, Symptoms or Conditions11
- No Information6
- No Known Impact Or Consequence To Patient3
- Urinary Tract Infection2
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 228 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 8, 2025Packaging Problem; Packaging Problem
IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SINGLE-USE SUCTION VALVE EXHIBITED A TEAR IN THE PACKING BOX OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23741679 ↗MalfunctionSep 16, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
IT WAS REPORTED THE SUCTION VALVE SNAPPED OFF IN THE SUCTION PORT. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23062633 ↗MalfunctionNov 27, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20795973 ↗MalfunctionSep 20, 2024Contamination; Contamination
IT WAS REPORTED, HAIR WAS FOUND INSIDE THE UNOPENED SINGLE USE SUCTION VALVE STERILIZED POUCH WHEN CHECKED BEFORE USE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20268607 ↗InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A THERAPEUTIC APPROACH TO PERIPHERAL LESIONS PROCEDURE, WHEN THE GUIDE SHEATH WAS INSERTED THROUGH THE FORCEPS PORT, AN UNIDENTIFIED FOREIGN OBJECT FELL FROM THE TIP OF THE ENDOSCOPE. THE SHEATH WAS REMOVED, AND THE FOREIGN OBJECT WAS COLLECTED. FURTHER, THE SUCTION SOUNDED STRANGE, BUT THE SHEATH WAS INSERTED INTO THE FORCEPS PORT AS IT WAS. THE SHEATH MAY HAVE COME OUT OF THE TIP OF THE ENDOSCOPE IN THE FORM OF PUSHING OUT THE FOREIGN BODY. THE PHYSICIAN DOES NOT THINK THAT THE FOREIGN SUBSTANCE CAME FROM AN OLYMPUS PRODUCT BUT WANTED TO HAVE IT CHECKED OUT JUST IN CASE. AN OLYMPUS REPRESENTATIVE EXPLAINED THAT THE GUIDE SHEATH WAS NOT DESIGNED TO CAUSE FOREIGN OBJECTS TO FALL BUT THE PHYSICIAN INSISTED TO HAVE IT CHECKED. THE CUSTOMER FURTHER EXPLAINED THAT WHEN USING THE SCOPE IN THE CASE, THE SUCTION WORSENED HALFWAY THROUGH, AND THE CUSTOMER SPECULATED THAT SOMETHING IN THE PATIENT'S MOUTH MAY HAVE BEEN SUCKED UP. REPORTEDLY, THERE WERE NO ABNORMALITIES FOUND WHEN CLEANING THE SCOPE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19333393 ↗MalfunctionApr 2, 2024Break; Break
IT WAS REPORTED THE SUCTION VALVE ON THE SCOPE POPPED OFF. THE SUCTION VALVE WAS PROPERLY ATTACHED, BUT THE COIL/SPRING BROKE DUE TO THE SUCTION LINE PULLING THE VALVE. THE SOLUTION TO THE ISSUE WAS GETTING A NEW VALVE, WHICH DELAYED THE PROCEDURE BY LESS THAN 10 MINUTES. THE ISSUE OCCURRED DURING BRONCHOSCOPY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19019426 ↗MalfunctionJan 26, 2024Device Reprocessing Problem; Device Reprocessing Problem
IT WAS OBSERVED THAT DURING THE DEVICE ESTIMATION, THE SINGLE-USE PISTONS OF THE BRONCHOSCOPES, THE CLIENT REUSED THE SINGLE-USE PISTONS ON THE BRONCHOSCOPES BY DISASSEMBLING THEM AND PASSING THEM THROUGH THE PEREACETIC ACID (PAA) WASHERS. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18589683 ↗InjuryAug 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
AN OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT AFTER COMPLETING A BRONCHOALVEOLAR LAVAGE TEST (BAL) USING THE EVIS LUCERA ELITE BRONCHOVIDEOSCOPE, A PIECE OF RUBBER WAS FOUND IN THE SUCTION BOTTLE. IT WAS POSSIBLE THAT THE RUBBER PIECE CAME OFF, FELL SOMEWHERE INSIDE THE PATIENT'S BODY AND WAS SUCTIONED OUT. IN ADDITION, DURING MANUAL WASHING AFTER THE PROCEDURE, THE SUCTION COULD NOT BE PERFORMED WHEN TRYING TO WASH WITH SUCTION. THEREFORE, IT WAS SUSPECTED THAT THE RUBBER ON THE SINGLE USE SUCTION VALVE CAME OFF AND COULD NOT BE SUCKED. NO ADDITIONAL TREATMENT WAS REQUIRED, AND THE PATIENT WAS NOT HOSPITALIZED. A PRE-USE INSPECTION WAS COMPLETED WITHOUT ANY ISSUES NOTED. CURRENTLY, THERE WAS NO PROBLEM WITH THE PATIENT'S HEALTH NOR WAS THERE ANY EFFECT NOTED ON THE PATIENT. THE RUBBER PIECES INSIDE THE BOTTLE HAVE ALREADY BEEN COLLECTED. ADDITIONAL INFORMATION INDICATED THAT THE FACILITY DOES NOT BELIEVE THERE WAS AN ISSUE WITH THE BRONCHOVIDEOSCOPE. THIS EVENT IS REPORTED UNDER THE FOLLOWING RELATED PATIENT IDENTIFIERS: (B)(6) - EVIS LUCERA ELITE BRONCHOVIDEOSCOPE, (B)(6) - SINGLE USE SUCTION VALVE. THIS MEDWATCH IS FOR PATIENT IDENTIFIER (B)(6).
Patient problems: Foreign Body In Patient
MAUDE report 17469995 ↗MalfunctionFeb 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS, DURING AN UNKNOWN PROCEDURE, THE SINGLE USE SUCTION VALVE (STERILE) COULD NOT STAY IN PLACE AND KEPT POPPING OUT OF THE SOCKET. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16453791 ↗MalfunctionJan 31, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE CUSTOMER REPORTED TO OLYMPUS THAT THE SINGLE-USE SUCTION VALVE POPS OUT OF THE PORT TOO EASILY DURING A PROCEDURE. THE CUSTOMER TESTED THE SUBJECT DEVICE WITH BOTH THE 180 AND 190 SERIES SCOPES, AND THE SAME ISSUE WAS REPORTED. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE, WITH NO REPORTS OF PATIENT HARM WERE ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16274532 ↗MalfunctionNov 18, 2022Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User
ON BEHALF OF THE CUSTOMER, AN OLYMPUS CUSTOMER SERVICE AGENT REPORTED AN OUT OF BOX FAILURE FOR THE SINGLE USE SUCTION VALVE (STERILE) DEVICE. THE SHIPPING PROVIDER (UPS) DELIVERED A PACKAGE CONTAINING THE SUBJECT DEVICE; HOWEVER, THE BOX WAS SOAKED AND DAMAGED SO THE CUSTOMER REFUSED THE SHIPMENT. A FEW DAYS LATER, UPS DELIVERED THE DEVICE IN A UPS REPACKAGED BOX. THE CUSTOMER ACCEPTED THE PACKAGED, AND UPON OPENING IT FOUND ALL THE ITEMS WERE DAMAGED FROM THE ORIGINAL ORDER. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15825195 ↗InjuryAug 3, 2022Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO THE OLYMPUS, TWO (2) PATIENT TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA AFTER HAVING PROCEDURES WITH THREE (3) OLYMPUS CYSTOSCOPES: CYF-VA2 SERIAL (B)(4), CYF-VA2 SERIAL (B)(4), AND CYF-VHA SERIAL (B)(4). THE TWO (2) PATIENTS PRESENTED WITH A FEVER AFTER SURGERY AND WERE DIAGNOSED WITH A URINARY TRACT INFECTION. BOTH PATIENTS WERE TREATED WITH ANTIBIOTICS AND HAVE RECOVERED. THE CYSTOSCOPES WERE CULTURED AND TWO (2) OF THE THREE (3) TESTED POSITIVE FOR MICROBIAL CONTAMINATION WITH PSEUDOMONAS AERUGINOS. CYF-VA2 SERIAL (B)(4) PSEUDOMONAS AERUGINOSA DETECTION. CYF-VA2 SERIAL (B)(4) NO DETECTION. CYF-VHA SERIAL (B)(4) PSEUDOMONAS AERUGINOSA DETECTION. THE SCOPE CLEANING PROCESS THAT THE FACILITY HAS CARRIED OUT SO FAR IS AS FOLLOWS: AFTER USE, APPEARANCE CLEANING WITH CLEANING AGENT; IMMERSION IN PROTEIN REMOVAL DETERGENT; RINSE CLEANING, IMMERSION IN GLUTARAL PREPARATION; RINSE CLEANING. IN THE PIPELINE FOR DRYING, ALCOHOL FLUSHING PROCESS WAS GENERALLY SUITABLE, BUT THE DISPOSABLE SUCTION VALVE (MAJ-209) WAS REUSED, THE SCOPE OPERATION PART WAS NOT SOAKED, THE CLEANING TOOL WAS INADEQUATE, AND THE T-SHAPED TUBE (MAJ-891) WAS DISASSEMBLED, CLEANED AND DISINFE
Patient problems: Urinary Tract Infection
MAUDE report 15157190 ↗InjuryAug 2, 2022Device Reprocessing Problem; Device Reprocessing Problem
THE CUSTOMER REPORTED TO THE OLYMPUS, TWO (2) PATIENT TESTED POSITIVE FOR PSEUDOMONAS AERUGINOSA AFTER HAVING PROCEDURES WITH THREE (3) OLYMPUS CYSTOSCOPES: (B)(6) SERIAL (B)(4), (B)(6) SERIAL (B)(4), AND (B)(6) SERIAL (B)(4). THE TWO (2) PATIENTS PRESENTED WITH A FEVER AFTER SURGERY AND WERE DIAGNOSED WITH A URINARY TRACT INFECTION. BOTH PATIENTS WERE TREATED WITH ANTIBIOTICS AND HAVE RECOVERED. THE CYSTOSCOPES WERE CULTURED AND TWO (2) OF THE THREE (3) TESTED POSITIVE FOR MICROBIAL CONTAMINATION WITH PSEUDOMONAS AERUGINOS. CYF-VA2 SERIAL (B)(4) PSEUDOMONAS AERUGINOSA DETECTION. CYF-VA2 SERIAL (B)(4) NO DETECTION . CYF-VHA SERIAL (B)(4) PSEUDOMONAS AERUGINOSA DETECTION. THE SCOPE CLEANING PROCESS THAT THE FACILITY HAS CARRIED OUT SO FAR IS AS FOLLOWS: AFTER USE, APPEARANCE CLEANING WITH CLEANING AGENT; IMMERSION IN PROTEIN REMOVAL DETERGENT; RINSE CLEANING, IMMERSION IN GLUTARAL PREPARATION; RINSE CLEANING. IN THE PIPELINE FOR DRYING, ALCOHOL FLUSHING PROCESS WAS GENERALLY SUITABLE, BUT THE DISPOSABLE SUCTION VALVE (MAJ-209) WAS REUSED, THE SCOPE OPERATION PART WAS NOT SOAKED, THE CLEANING TOOL WAS INADEQUATE, AND THE T-SHAPED TUBE (MAJ-891) WAS DISASSEMBLED, CLEANED AND DISINFECT
Patient problems: Urinary Tract Infection
MAUDE report 15148217 ↗MalfunctionJul 26, 2021Device Handling Problem; Device Handling Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM THE USER THAT DURING THE UNSPECIFIED TIMING, IT WAS FOUND THAT THE SUCTION WAS WEAK. ALSO OMSC WAS INFORMED FROM THE USER THAT THE USER HAD STERILIZED AND REUSED THE SUBJECT DEVICE. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12223468 ↗MalfunctionJul 14, 2020Break; Break
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPY, THE SUBJECT DEVICE WAS USED. THE SUCTION CONNECTOR OF THE DEVICE BROKE OFF WHEN THE DEVICE WAS ATTACHED TO THE ENDOSCOPE FOR PREPARING THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE SUCTION CONNECTOR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10270675 ↗MalfunctionJul 14, 2020Break; Break
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED THAT DURING AN ENDOSCOPY, THE SUBJECT DEVICE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THE SUCTION CONNECTOR OF THE DEVICE BROKE OFF WHEN THE USER REMOVED THE DEVICE AFTER THE PROCEDURE. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE SUCTION CONNECTOR. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. THE USER FACILITY DID NOT PROVIDE OTHER DETAILED INFORMATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10270591 ↗MalfunctionJun 26, 2020Fitting Problem; Fitting Problem
THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC BRONCHOSCOPY THE SUCTION VALVE FELL OUT OF THE SCOPE. AFTER FALLING OUT OF THE SCOPE, THE VALVE COULD NOT BE REINSERTED FOR PROPER FUNCTION. DUE TO THE VALVE ISSUE, THE MEDICATION COULD NOT BE ADMINISTERED PROPERLY TO THE PATIENT AND AS A RESULT, THE PATIENT EXPERIENCED SOME DISCOMFORT. THE USER FACILITY DID REPORT THAT THE INTENDED PROCEDURE WAS COMPLETED WITH THE SAME SET OF EQUIPMENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10203973 ↗MalfunctionApr 29, 2020Loose or Intermittent Connection; Loose or Intermittent Connection
THE CUSTOMER REPORTED TO OLYMPUS THAT DURING A BRONCHOSCOPY PROCEDURE THE SUCTION VALVE WAS FOUND LOOSE AND WAS POPPING OUT OF THE DEVICE¿S PORT. THE INTENDED PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME SUCTION VALVE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10011485 ↗MalfunctionFeb 19, 2020Break; Break
THE PROCEDURE WAS A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND (EBUS). THE USER FACILITY REPORTED THAT THERE WAS NO INJURY TO THE PATIENT AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THE USER FACILITY STATED THAT THE PROBLEM OCCURRED AFTER THE PROCEDURE WAS COMPLETED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9729737 ↗MalfunctionFeb 19, 2020Break; Break
DURING AN ENDOSCOPY, THE SUBJECT DEVICE WAS USED. THE INTENDED PROCEDURE WAS COMPLETED WITH THE SUBJECT DEVICE. THERE WAS NO PATIENT INJURY REPORTED. THE SUCTION CONNECTOR OF THE DEVICE BROKE OFF WHEN THE USER REMOVED THE DEVICE AFTER THE PROCEDURE. THIS IS THE REPORT REGARDING THE BREAKAGE OF THE SUCTION CONNECTOR.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9724832 ↗MalfunctionFeb 3, 2020Break; Break
THE SERVICE CENTER RECEIVED A REPORT OF SIX SINGLE USE SUCTION VALVES (MAJ-209) ALL FROM THE SAME LOT NUMBER 8XH, THAT WERE BREAKING OFF EITHER DURING OR AFTER AN UNSPECIFIED PROCEDURE. THE SIX VALVES FROM LOT 8XH WERE PREVIOUSLY REPORTED AS PART OF A DEVICE RECALL, RECALL REPORT NUMBER Z-2148-2019, INITIATED ON APRIL 1, 2019. IT IS NOT KNOWN IF THE SIX VALVES REPORTED, BROKE OFF BEFORE, DURING OR AFTER A PROCEDURE, OR IF THE SUCTION VALVES WERE USED ON ONE PATIENT OR MULTIPLE PATIENTS DURING ONE OR MULTIPLE PROCEDURES. THIS IS FOR THE SIXTH SUCTION VALVE THAT BROKE OFF OUT OF THE SIX VALVES REPORTED. REPORT 6 OF 6.
Patient problems: No Information
MAUDE report 9660870 ↗MalfunctionFeb 3, 2020Break; Break
THE SERVICE CENTER RECEIVED A REPORT OF SIX SINGLE USE SUCTION VALVES (MAJ-209) ALL FROM THE SAME LOT NUMBER 8XH, THAT WERE BREAKING OFF EITHER DURING OR AFTER AN UNSPECIFIED PROCEDURE. THE SIX VALVES FROM LOT 8XH WERE PREVIOUSLY REPORTED AS PART OF A DEVICE RECALL, RECALL REPORT NUMBER Z-2148-2019, INITIATED ON APRIL 1, 2019. IT IS NOT KNOWN IF THE SIX VALVES REPORTED, BROKE OFF BEFORE, DURING OR AFTER A PROCEDURE, OR IF THE SUCTION VALVES WERE USED ON ONE PATIENT OR MULTIPLE PATIENTS DURING ONE OR MULTIPLE PROCEDURES. THIS IS FOR THE FIFTH SUCTION VALVE THAT BROKE OFF OUT OF THE SIX VALVES REPORTED. REPORT 5 OF 6.
Patient problems: No Information
MAUDE report 9660743 ↗MalfunctionFeb 3, 2020Break; Break
THE SERVICE CENTER RECEIVED A REPORT OF SIX SINGLE USE SUCTION VALVES (MAJ-209) ALL FROM THE SAME LOT NUMBER 8XH, THAT WERE BREAKING OFF EITHER DURING OR AFTER AN UNSPECIFIED PROCEDURE. THE SIX VALVES FROM LOT 8XH WERE PREVIOUSLY REPORTED AS PART OF A DEVICE RECALL, RECALL REPORT NUMBER Z-2148-2019, INITIATED ON APRIL 1, 2019. IT IS NOT KNOWN IF THE SIX VALVES REPORTED, BROKE OFF BEFORE, DURING OR AFTER A PROCEDURE, OR IF THE SUCTION VALVES WERE USED ON ONE PATIENT OR MULTIPLE PATIENTS DURING ONE OR MULTIPLE PROCEDURES. THIS IS FOR THE FOURTH SUCTION VALVE THAT BROKE OFF OUT OF THE SIX VALVES REPORTED. REPORT 4 OF 6.
Patient problems: No Information
MAUDE report 9660104 ↗MalfunctionFeb 3, 2020Break; Break
THE SERVICE CENTER RECEIVED A REPORT OF SIX SINGLE USE SUCTION VALVES (MAJ-209) ALL FROM THE SAME LOT NUMBER 8XH, THAT WERE BREAKING OFF EITHER DURING OR AFTER AN UNSPECIFIED PROCEDURE. THE SIX VALVES FROM LOT 8XH WERE PREVIOUSLY REPORTED AS PART OF A DEVICE RECALL, RECALL REPORT NUMBER Z-2148-2019, INITIATED ON APRIL 1, 2019. IT IS NOT KNOWN IF THE SIX VALVES REPORTED, BROKE OFF BEFORE OR AFTER A PROCEDURE, OR IF THE SUCTION VALVES WERE USED ON ONE PATIENT OR MULTIPLE PATIENTS DURING ONE OR MULTIPLE PROCEDURES. THIS IS FOR THE FIRST SUCTION VALVE THAT BROKE OFF OUT OF THE SIX VALVES REPORTED. REPORT 1 OF 6.
Patient problems: No Information
MAUDE report 9660083 ↗MalfunctionFeb 3, 2020Break; Break
THE SERVICE CENTER RECEIVED A REPORT OF SIX SINGLE USE SUCTION VALVES (MAJ-209) ALL FROM THE SAME LOT NUMBER 8XH, THAT WERE BREAKING OFF EITHER DURING OR AFTER AN UNSPECIFIED PROCEDURE. THE SIX VALVES FROM LOT 8XH WERE PREVIOUSLY REPORTED AS PART OF A DEVICE RECALL, RECALL REPORT NUMBER Z-2148-2019, INITIATED ON APRIL 1, 2019. IT IS NOT KNOWN IF THE SIX VALVES REPORTED, BROKE OFF BEFORE OR AFTER A PROCEDURE, OR IF THE SUCTION VALVES WERE USED ON ONE PATIENT OR MULTIPLE PATIENTS DURING ONE OR MULTIPLE PROCEDURES. THIS IS FOR THE SECOND SUCTION VALVE THAT BROKE OFF OUT OF THE SIX VALVES REPORTED. REPORT 2 OF 6.
Patient problems: No Information
MAUDE report 9660053 ↗
Other Nasopharyngoscope (Flexible Or Rigid) devices
- ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE OLYMPUS LTF-S190-10Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)785 reports
- NA 242268Medos International Sàrl · Nasopharyngoscope (flexible or rigid)573 reports
- EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180Olympus Medical Systems Corp. · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)3 recalls1 death408 reports
- VIVIDEO VNL9-CPHoya Corporation · Nasopharyngoscope (Flexible Or Rigid)389 reports
- PENTAX FNL-10RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)322 reports
- SINGLE USE BIOPSY VALVE MAJ-210Olympus Medical Systems Corp. · Nasopharyngoscope (Flexible Or Rigid)1 recall221 reports
- PENTAX FNL-7RP3Hoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)227 reports
- PENTAX FNL-10RBSHoya Corporation · NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)171 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page