Single use adaptor biopsy valve MAJ-1414Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 04953170181009), received between Oct 3, 2018 and Dec 2, 2025 — classified as 3 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (22 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 25 most recent of 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE SINGLE-USE ADAPTER BIOPSY VALVE LEAKED DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE. 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 23694208 ↗
• InjuryDec 13, 2024Break; Break

  IT WAS REPORTED THE BIOPSY VALVE HAD A SMALL PIECE BREAKAWAY AND HAD TO BE REMOVED FROM THE AIRWAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929441 ↗
• InjuryDec 13, 2024Break; Material Disintegration; Break; Material Disintegration

  IT WAS REPORTED THE BIOPSY VALVE HAD A SMALL PIECE BREAKAWAY AND HAD TO BE REMOVED FROM THE AIRWAY. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926305 ↗
• MalfunctionJan 3, 2023Leak/Splash; Mechanical Problem; Leak/Splash; Mechanical Problem

  COMPANY REPRESENTATIVE REPORTED FAULTY EGNA-U401SX4021 (ASPIRATION NEEDLE)-SINGLE USE. ACCORDING TO THE REPORT, THE FAULT IS WITH THE VACLOK SYRINGE SUPPLIED WITHIN THE PACK. THE RUBBER PIECE THAT HELPS TO CREATE THE VACUUM SEEMS TO HAVE BECOME DISLODGED. PER THE REPORT, THE ISSUE OCCURRED DURING PROCEDURE. THE KIT WAS REMOVED AND REPLACED WITH NEW KIT (NEW TBNA PROCEDURE PACK) AND THE INTENDED PROCEDURE (THERAPEUTIC ENDOBRONCHIAL ULTRASOUND-GUIDED TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) WAS COMPLETED. NO HARM WAS REPORTED. ACCORDING TO THE REPORT , IT CAUSED THE PROCEDURE TO BE LONGER THAN REQUIRED HOWEVER, THE PATIENT WAS REPORTED TO BE "WELL" . NO HARM WAS REPORTED, NO PATIENT INJURY, NO USER INJURY REPORTED DUE TO THE EVENT. ADDITIONALLY, IT WAS REPORTED THAT THE LIDOCAINE WAS LEAKING FROM THE MAJ-1414 BIOPSY ADAPTOR . A FOLLOW UP IS IN PROGRESS ASKING FOR MORE CLARIFICATION (LEAK ETC.). THIS REPORT IS BEING SUBMITTED FOR THE LEAKING OF LIDOCAINE FROM (MAJ-1414) BIOPSY ADAPTOR . THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16087567 ↗
• InjuryAug 5, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED TO OLYMPUS DURING A BRONCHOSCOPY, A STUDENT WAS SPLASHED IN THE EYE WITH BLOODY FLUID FROM THE SUBJECT DEVICE, ONE WAY VALVE. THE NEEDLE WAS WITHDRAWN, AND WHILE THE RESPIRATORY THERAPIST WAS FLUSHING THE SAMPLE OUT OF THE SCOPE, THE PATIENT COUGHED. THE SUBJECT DEVICE DID NOT SEAL AND BLOOD AND BODY FLUID CAME OUT THROUGH THE ENDOSCOPE VALVE AND INTO THE STUDENT'S EYE. THE STUDENT WAS SENT TO THE EMERGENCY ROOM FOR THE EXPOSURE.

  Patient problems: Unspecified Eye / Vision Problem

  MAUDE report 15175766 ↗
• MalfunctionJul 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THE VALVE WAS LEAKING AND SPRAYING WATER DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. THE LEAK HAPPENED BEFORE THE VALVE WAS MANIPULATED AND PRIOR TO THE NEEDLE OR SYRINGE BEING APPLIED TO THE VALVE. THE USER COVERED THE VALVE WITH A TOWEL IN ORDER TO FINISH THE PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14892545 ↗
• MalfunctionAug 5, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE OLYMPUS REPRESENTATIVE, AT THE BEGINNING OF A DIAGNOSTIC ENDOBRONCHIAL ULTRASOUND BRONCHOSCOPY (EBUS), THE SINGLE USE ADAPTOR BIOPSY VALVE WAS LEAKING. THE SINGLE USE ADAPTOR BIOPSY VALVE WAS USED WITH EVIS EXERA II ULTRASONIC BRONCHOFIBERVIDEOSCOPE AND THE SINGLE USE ASPIRATION NEEDLE. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE WITH NO DELAY AND NO PATIENT INJURY. THE DEVICE HAD BEEN INSPECTED PRIOR TO USE AND WAS FOUND TO BE INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12283106 ↗
• MalfunctionJun 25, 2021Device Slipped; Device Slipped

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY THE CUSTOMER THAT DURING AN EXAMINATION USING THE SUBJECT DEVICE(MAJ-1414) WHEN IT WAS ATTACHED TO THE BIOPSY CHANNEL OF THE ENDOSCOPE, THE FOLLOWING EVENT OCCURRED. THE NEEDLE SLIPPED 4 TIMES DURING THE EXAMINATION. THERE WAS NO PATIENT INJURY REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY OUR SERVICE DEPARTMENT. THE NEEDLE IN QUESTION GOES VERY LOOSELY ON THE MAJ-1414(DISPOSABLE BIOPSY VALVE ADAPTER) - AND COMES OFF ACCORDINGLY. A SLIGHT NOISE FROM THE ENGAGEMENT(FIXATION) CAN BE HEARD AND FELT, BUT THE ENGAGEMENT, IN THIS CASE, IS INSUFFICIENT. THE SLIDER CAN RELEASE ITSELF DURING NORMAL HANDLING WITHOUT THE USER NOTICING. COMPARISON NEEDLE - HERE YOU DON'T HEAR ANY CLICK/LOCKING AT ALL AND THE SLIDER CAN ONLY BE PUT ON THE MAJ-1414 WITH FORCE. BUT IT HOLDS BETTER. THIS IS ALSO NOT A CORRECT ASSEMBLY, BECAUSE THE LOCKING MECHANISM SHOULD ALWAYS WORK NOTICEABLY AND AUDIBLY, WITH SUFFICIENT FIXATION. WE USED MAJ-1414 WHICH WAS SUPPLIED WITH THE ENDOSCOPE WHEN TESTING. THE SAME FOR BOTH NEEDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12065263 ↗
• MalfunctionMar 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED, THE SINGLE USE ADAPTOR BIOPSY VALVE BEGAN LEAKING AND SPRAYING WATER DURING A PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE USER COVERED THE VALVE WITH A TOWEL AND THEY CONTINUED WORKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11407522 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT TEN OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658876 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT NINE OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658844 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT EIGHT OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658794 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT SEVEN OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658776 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT SIX OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658773 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT 5 OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658664 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT FOUR OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658029 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT THREE OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10658008 ↗
• MalfunctionOct 9, 2020Use of Device Problem; Use of Device Problem

  DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE, IT WAS REPORTED THAT FLUID SPLASHED OUT OF THE VALVE CAP AND ONTO THE PHYSICIAN. THIS OCCURS WHEN THE PATIENT COUGHS DURING THE PROCEDURE, NOT DURING THE WITHDRAWAL OF THE EBUS NEEDLE. NO PATIENT OR USER INJURY WAS REPORTED. THE USER FACILITY STATED MULTIPLE BIOPSY VALVES LEAKED DURING PROCEDURES PERFORMED BY SEVERAL DIFFERENT PRACTITIONERS. THE EVENTS REPORTED OCCURRED INTERMITTENTLY OVER THE LAST 12-24 MONTHS. THE USERS BELIEVE THAT THE BIOPSY VALVE CAP, ONCE PUNCTURED WITH AN EBUS NEEDLE, DOES NOT SEAL ANYMORE. THE VALVES WERE INSTALLED CORRECTLY AND WERE NOT BROKEN PRIOR TO BEING INSTALLED. THE USER FACILITY WAS IN-SERVICED ON PROPER EBUS NEEDLE USE BY THE LOCAL SALES REPRESENTATIVE. THIS IS REPORT TWO OF TEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10657972 ↗
• MalfunctionOct 9, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED." IT WAS REPORTED THE END USERS EXPERIENCED LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP, BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. STAFF REPORTED THAT THE VALVE WAS PROPERLY PLACED ON THE ENDOSCOPE. THIS REPORT IS #1 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10657819 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED¿ AND THAT THEY WERE EXPERIENCING LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. IT WAS REPORTED THAT PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. IT WAS REPORTED THAT END USERS PROPERLY PLACED THE VALVE ON THE ENDOSCOPE. THIS REPORT IS # 19 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645468 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED¿ AND THAT THEY WERE EXPERIENCING LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. IT WAS REPORTED THAT PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. IT WAS REPORTED THAT END USERS PROPERLY PLACED THE VALVE ON THE ENDOSCOPE. THIS REPORT IS # 18 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645404 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED¿ AND THAT THEY WERE EXPERIENCING LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. IT WAS REPORTED THAT PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. IT WAS REPORTED THAT END USERS PROPERLY PLACED THE VALVE ON THE ENDOSCOPE. THIS REPORT IS # 17 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645304 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED¿ AND THAT THEY WERE EXPERIENCING LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. IT WAS REPORTED THAT PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. IT WAS REPORTED THAT END USERS PROPERLY PLACED THE VALVE ON THE ENDOSCOPE. THIS REPORT IS # 15 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645252 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED¿ AND THAT THEY WERE EXPERIENCING LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. IT WAS REPORTED THAT PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. IT WAS REPORTED THAT END USERS PROPERLY PLACED THE VALVE ON THE ENDOSCOPE. THIS REPORT IS # 16 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645214 ↗
• MalfunctionOct 7, 2020Leak/Splash; Leak/Splash

  OLYMPUS WAS NOTIFIED THAT THE BIOPSY VALVE WAS NOT ''SEALED¿, AND THAT THEY WERE EXPERIENCING LEAKING WHICH INCREASED WITH PATIENT COUGHING. THE SECRETIONS WERE EXPELLED FROM THE BIOPSY CAP BEFORE AND/OR AFTER THE NEEDLE WAS INSERTED THROUGH THE CAP. IT WAS REPORTED THAT PATIENT SECRETIONS SPLASHED ON THE FACE OF CAREGIVERS ON SEVERAL OCCASIONS. DURING THE PROCEDURES, THE STAFF WORE SAFETY GOGGLES, N95 MASKS, GOWNS AND GLOVES. THERE WAS NO INJURY REPORTED. NO EXPOSURE TESTING HAS BEEN PERFORMED FOLLOWING THE EXPOSURES. IT WAS REPORTED THAT END USERS PROPERLY PLACED THE VALVE ON THE ENDOSCOPE. THIS REPORT IS # 14 OF 19 FOR EXPOSURE RELATED TO "BIOPSY VALVE NOT SEALED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645152 ↗