SMOKE EVACUATION FOOT SWITCH MAJ-1939Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170324185), received between Sep 27, 2022 and Feb 22, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Decrease in Pressure” (2 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.

• MalfunctionFeb 22, 2024Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED THAT THE SMOKE EVACUATION FOOT SWITCH EXHIBITED AN ISSUE WHERE THE FOOT SWITCH WAS NOT PRESSED. THE ISSUE OCCURRED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758989 ↗
• MalfunctionOct 10, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  THE CUSTOMER REPORTED TO OLYMPUS, THE PINCH VALVE OF THE SMOKE EVACUATION FOOT SWITCH DID NOT GO DOWN SMOOTHLY WHEN THE FOOT PEDAL WAS PRESSED. IT WENT DOWN IN SMALL INCREMENTS INSTEAD. THE ISSUE WAS FOUND DURING AN UNSPECIFIED 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 17909563 ↗
• MalfunctionDec 16, 2022Self-Activation or Keying; Self-Activation or Keying

  THE CUSTOMER REPORTED THAT, DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SMOKE EVACUATION FUNCTION WAS ACTIVATED AND PNEUMOPERITONEUM PRESSURE DECREASED, EVEN THOUGH THE SUBJECT DEVICE WAS NOT USED TO OPERATE THE SMOKE EVACUATION FUNCTION. AFTER REINFLATION AND PRESSURE RETURN, THE PROCEDURE WAS CONTINUED AND COMPLETED. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THIS REPORT IS FOR THE MODEL MAJ-1939 FOOT SWITCH. THE MODEL UHI-4 OLYMPUS INSUFFLATION UNIT WAS REPORTED ON MEDWATCH# 3002808148-2022-03783 WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15995286 ↗
• MalfunctionOct 14, 2022Decrease in Pressure; Decrease in Pressure

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SMOKE EVACUATION FUNCTION WAS ACTIVATED, AND THE PNEUMOPERITONEUM PRESSURE DECREASED, EVEN THOUGH THE SMOKE EXHAUST FUNCTION WAS NOT OPERATED BY THE FOOT SWITCH. AFTER THE AIR WAS SENT AGAIN AND THE PRESSURE WAS RELEASED, THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED USING THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE PHENOMENON REPORTEDLY OCCURRED SEVERAL TIMES. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENTS; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR THE SMOKE EVACUATION FOOT SWITCH THAT WAS IN USE AT THE TIME OF THE EVENT. THE UHI-4 INSUFFLATION UNIT WAS REPORTED ON MEDWATCH 8010047-2022-11906 WITH PATIENT IDENTIFIER (B)(6). THE MAJ-591 SUCTION TUBE WAS REPORTED ON MEDWATCH 8010047-2022-11478 WITH PATIENT IDENTIFIER (B)(6). A SECOND ISSUE WITH THE UHI-4 INSUFFLATION UNIT WAS REPORTED ON MEDWATCH 8010047-2022-11907 WITH PATIENT IDENTIFIER (B)(6). A SECOND ISSUE WITH THE MAJ-1939 FOOT SWITCH WAS REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). A SECOND ISSUE WITH THE MAJ-591 SUCTION TUBE WAS REPORTED ON ME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15612153 ↗
• MalfunctionOct 14, 2022Decrease in Pressure; Decrease in Pressure

  THE CUSTOMER REPORTED THAT DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE, THE SMOKE EVACUATION FUNCTION WAS ACTIVATED, AND THE PNEUMOPERITONEUM PRESSURE DECREASED, EVEN THOUGH THE SMOKE EXHAUST FUNCTION WAS NOT OPERATED BY THE FOOT SWITCH. AFTER THE AIR WAS SENT AGAIN AND THE PRESSURE WAS RELEASED, THE PROCEDURE WAS CONTINUED AND SUCCESSFULLY COMPLETED USING THE SUBJECT DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE PHENOMENON REPORTEDLY OCCURRED SEVERAL TIMES. ADDITIONAL DETAILS WERE REQUESTED REGARDING THE REPORTED EVENTS; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED. THIS REPORT IS FOR THE SMOKE EVACUATION FOOT SWITCH THAT WAS IN USE AT THE TIME OF THE EVENT. THE UHI-4 INSUFFLATION UNIT WAS REPORTED ON MEDWATCH 8010047-2022-11907 WITH PATIENT IDENTIFIER (B)(6). THE MAJ-591 SUCTION TUBE WAS REPORTED ON MEDWATCH 8010047-2022-11895 WITH PATIENT IDENTIFIER (B)(6). A SECOND ISSUE WITH THE UHI-4 INSUFFLATION UNIT WAS REPORTED ON MEDWATCH 8010047-2022-11906 WITH PATIENT IDENTIFIER (B)(6). A SECOND ISSUE WITH THE MAJ-1939 FOOT SWITCH WAS REPORTED ON THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6). A SECOND ISSUE WITH THE MAJ-591 SUCTION TUBE WAS REPORTED ON ME

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15610866 ↗
• MalfunctionSep 27, 2022Pressure Problem; Pressure Problem

  THE CUSTOMER WAS PERFORMING A THERAPEUTIC PROCEDURE INVOLVING AN OLYMPUS HIGH FLOW INSUFFLATION UNIT PAIRED WITH AN OLYMPUS SMOKE EVACUATION FOOT SWITCH. DURING THE LATER PART OF THE PROCEDURE, THE PHYSICIAN STEPPED ON THE SMOKE EXHAUST FOOTSWITCH, AND ALL THE GAS IN THE ABDOMINAL CAVITY ESCAPED. REPORTEDLY, THE PHYSICIAN WAITED FOR THE GAS TO REACCUMULATE TO CONTINUE AND COMPLETE TO THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED AS A RESULT OF THIS EVENT. THIS REPORT IS 2 OF 2, SUBMITTED TO CAPTURE THE SMOKE EVACUATION FOOT SWITCH. FOR EVENT 1 OF 2, BEING SUBMITTED TO CAPTURE THE HIGH FLOW INSUFFLATION UNIT, PLEASE SEE REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15494075 ↗