SUCTION VALVE MAJ-207Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04953170063428), received between Feb 12, 2021 and Nov 18, 2024 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Break; Break

  IT WAS REPORTED THAT THE SUCTION BUTTON/VALVE SUDDENLY BROKE AND COULD NOT BE REMOVED FROM THE ENDOSCOPE DURING A BRONCHOSCOPY PROCEDURE. AS SUCH, THE PROCEDURE/EXAMINATION WAS INTERRUPTED AND THE PATIENT PRESENTED WITH CHEST TIGHTNESS, RESPIRATORY INSUFFICIENCY AND ARRHYTHMIA. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A SIMILAR DEVICE WITH A DELAY OF 20 MINUTES. FOLLOW-UP INFORMATION FOR THE EVENT IS PENDING AT THE TIME OF THE REPORT.

  Patient problems: Chest Pain; Ectopic Heartbeat; Respiratory Insufficiency

  MAUDE report 20707761 ↗
• MalfunctionJun 7, 2024Misassembled During Installation; Misassembled During Installation

  IT WAS REPORTED THAT THE SUCTION VALVE WAS CONNECTED WHEN THE CONNECTING TUBE SHOULD HAVE BEEN USED. THE ISSUE OCCURRED DURING REPROCESSING. THERE WERE NO REPORTS OF INFECTIONS OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19487961 ↗
• MalfunctionNov 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE SUCTION VALVE, HAD THE RUBBER RING REMAIN IN THE CONNECTION ON THE SCOPE. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS UNKNOWN. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18213668 ↗
• MalfunctionNov 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THE PRODUCT PROBLEM CAUSED A DELAY OF ABOUT 1.5 MINUTES. THE PROCEDURE WAS COMPLETED WITH NEW SUCTION VALVE. THERE WAS NO PROCEDURE POSTPONEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18186200 ↗
• MalfunctionNov 15, 2023Degraded; Fluid/Blood Leak; Loose or Intermittent Connection; Degraded; Fluid/Blood Leak; Loose or Intermittent Connection

  THE CUSTOMER CONFIRMED EVENT OCCURRED DURING THE PROCEDURE. THE DEVICE WAS SWITCHED OUT FOR A NEW SUCTION VALVE MAJ-207 LOT NUMBER UNKNOWN. THERE WERE NO PROCEDURAL DELAYS. IT IS UNKNOWN IF THE PATIENT HAD ANY PRE-EXISTING CONDITIONS AT THE TIME OF THE EVENT. IT IS UNKNOWN IF THE DEVICE INSPECTED PRIOR TO USAGE. IT IS UNKNOWN IF THE PROCEDURE WAS THERAPEUTIC OR DIAGNOSTIC, AND THE PATIENT¿S CONDITION IS UNKNOWN. THERE WAS NO PROLONGED HOSPITAL STAY AND THE PATIENT WAS DISCHARGED AS PLANNED. NO FURTHER INFORMATION CAN BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141943 ↗
• MalfunctionMar 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A RECEIPT INSPECTION, THE SUCTION VALVE COULD NOT BE CORRECTLY ATTACHED TO AN ENDOSCOPE AND EASILY DETACHES, WHICH CAUSED THE VALVE TO MOVE OUT OF POSITION WHEN MOVING THE ENDOSCOPE. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16593134 ↗
• MalfunctionJan 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE REPORTED EVENT OCCURRED DURING NORMAL BRONCHOSCOPY OR ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE WITH PUNCTURE. THE PROCEDURE WAS COMPLETED, BUT THE VALVE NEEDED TO BE REPLACED. THE CUSTOMER REPORTED THERE WAS NO CLINICALLY RELEVANT PROLONGATION OF THE PROCEDURE DUE TO THE DEFECT. HOWEVER, IT DISTURBS THE COURSE OF THE PROCEDURE IF YOU HAVE TO KEEP HOLDING THE VALVE WITH THE SUCTION HOSE. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16230842 ↗
• MalfunctionDec 22, 2021Product Quality Problem; Defective Device; Product Quality Problem; Defective Device

  AS REPORTED, AT DELIVERY ACCEPTANCE DURING INSPECTION, IT WAS FOUND THE SUCTION BUTTONS WERE LOOSE WHEN INSTALLED ON THE SCOPE AND EASY TO FALL OFF, IT HAPPENED FOR ALL SCOPES. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13067624 ↗
• MalfunctionDec 22, 2021Product Quality Problem; Defective Device; Product Quality Problem; Defective Device

  AS REPORTED, AT DELIVERY ACCEPTANCE, IT WAS FOUND THE SUCTION BUTTONS WERE LOOSE WHEN INSTALLED ON THE SCOPE AND EASY TO FALL OFF. THERE IS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13066987 ↗
• MalfunctionDec 16, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER, DURING A THERAPEUTIC BRONCHOSCOPY PROCEDURE, THE SUCTION VALVE WOULD COME LOOSE FROM THE BRONCHOSCOPES AT THE SLIGHTEST MOVEMENT. ANOTHER ENDOSCOPE WAS TRIED WITH THE VALVE, HOWEVER, THE ISSUE REMAINED. THE RUBBER RING WAS NOT LEFT IN THE BRONCHOSCOPE. THE INTENDED PROCEDURE WAS COMPLETED SIMILAR DEVICE AND NO SURGICAL DELAY. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018050 ↗
• MalfunctionJul 2, 2021Suction Failure; Suction Failure

  THE USER FACILITY INFORMED OLYMPUS (B)(4) THAT SOME OF THE SUCTION VALVES REPORTEDLY HAVE NO SUCTION DURING TESTING WITH A 180 SERIES TYPE BRONCHOSCOPE. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR 2 OF 2 SUCTION VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112153 ↗
• MalfunctionJul 2, 2021Suction Failure; Suction Failure

  THE USER FACILITY INFORMED OLYMPUS ((B)(6)) THAT SOME OF THE SUCTION VALVES REPORTEDLY HAVE NO SUCTION DURING TESTING WITH A 180 SERIES TYPE BRONCHOSCOPE. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR 1 OF 2 SUCTION VALVES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112151 ↗
• MalfunctionFeb 12, 2021Break; Break

  DURING THE PROCEDURE, THE USER FOUND THAT THE DEVICE (MAJ-207, SUCTION VALVES) WAS FALLEN OUT SEVERAL TIMES BECAUSE THE DEVICE WAS NOT FITTED TO THE ENDOSCOPE CHANNEL PROPERLY. THE USER ALSO FOUND THAT A PART OF THE RUBBER OF THE DEVICE WAS PEELED OFF AND CLOGGED INSIDE THE SCOPE. 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 11320305 ↗