Cylinder hose with switch-over valve (Pin-index) MAJ-1985Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04953170324208), received between Dec 3, 2019 and May 28, 2026 — classified as 1 injury, 22 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (11 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Detachment of Device or Device Component

  THE CUSTOMER RETURNED THE CYLINDER HOSE WHICH IS AN OLYMPUS ASSET WITH NO REPORTED COMPLAINT. DURING THE DEVICE ANALYSIS, MISSING PACKING JOINT RING ON A JOKE SIDE CAUSING A LEAK WAS FOUND. IT WAS DETERMINED THAT THE RING NEEDED TO BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25319491 ↗
• MalfunctionMar 31, 2026Gas/Air Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CYLINDER HOSE HAD A RIPPED PACKING JOINT (O-RING) AND CO2 LEAKAGE FROM THE HOSE. THE ISSUE OCCURRED DURING AN ENDOSCOPIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742482 ↗
• MalfunctionMar 26, 2026Degraded

  IT WAS REPORTED THAT THE CYLINDER HOSE HAD THE PACKING JOINT EXPANDED. THE ISSUE WAS FOUND DURING MAINTENANCE. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24697940 ↗
• MalfunctionMar 10, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE CYLINDER HOSE HAD CARBON DIOXIDE LEAKED FROM HOSE AT THE CONNECTOR ASSEMBLY. THE EVENT OCCURRED DURING INSPECTION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559543 ↗
• MalfunctionFeb 10, 2026Degraded

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307239 ↗
• MalfunctionAug 19, 2025Material Integrity Problem; Material Integrity Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22840116 ↗
• MalfunctionApr 22, 2024Loose or Intermittent Connection; Gas/Air Leak; Loose or Intermittent Connection; Gas/Air Leak

  IT WAS REPORTED, THE CYLINDER HOSE HAD AN AIR LEAK AND THE PACKING JOINT GASKET HAD HIGH PRESSURE HOSE WITH A LOOSE SWITCHING VALVE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19153503 ↗
• MalfunctionApr 18, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CYLINDER HOSE HAD A GAS LEAK. THIS WAS DISCOVERED AT PREPARATION FOR USE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19137871 ↗
• MalfunctionFeb 23, 2024Break; Break

  IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE CYLINDER HOSE'S "B" O-RING WAS CRACKED. THERE WERE NO REPORTS OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18768588 ↗
• MalfunctionOct 13, 2023Gas/Air Leak; Gas/Air Leak

  A BIOMEDICAL ENGINEER REPORTED TO OLYMPUS, THE CYLINDER HOSE HAD CARBON DIOXIDE (CO2) LEAKING OUT OF THE CART. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17936514 ↗
• MalfunctionAug 21, 2023Gas/Air Leak; Gas/Air Leak

  THE SALES REPRESENTATIVE REPORTED TO OLYMPUS, THERE WAS A GAS LEAKAGE FROM CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX) WHEN CONNECTED TO THE UHI DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17592366 ↗
• MalfunctionAug 1, 2023Fluid/Blood Leak; Fluid/Blood Leak

  AN OLYMPUS SALES REPRESENTATIVE (REP) CALLED IN TO REPORT THAT THE CUSTOMER¿S OLYMPUS CYLINDER HOSE WAS LEAKING. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434327 ↗
• MalfunctionJun 6, 2023Connection Problem; Connection Problem

  THE CUSTOMER REPORTED THAT HIS OLYMPUS CYLINDER HOSE WITH SWITCH-OVER VALVE HAD COMPROMISED HIGH PRESSURE HOSE CONNECTION. ACCORDING TO THE INITIAL REPORTER THE O-RING ON HIS UNIT WAS BAD. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17070374 ↗
• MalfunctionMay 22, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A PRE-USE INSPECTION FOR A DIAGNOSTIC COLONOSCOPY PROCEDURE, THE CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX) HAD FLUID LEAK FROM ITS B-HOSE. IT WAS NOTED, THE PACKING WAS REPLACED, HOWEVER, THE LEAK PERSISTED. THE A-HOSE OF THE DEVICE WAS USED TO COMPLETE THE INTENDED PROCEDURE. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. ADDITIONAL INFORMATION RECEIVED INDICATES THAT USERS ATTEMPTED TO INVESTIGATE CAUSAL RELATIONSHIP BETWEEN THE CONNECTION LOAD AND GAS LEAKAGE DUE TO THE INCREASED DISTANCE BETWEEN THE HOSE AND THE CYLINDER. THERE WAS ALSO A PROBLEM WITH THE LEAKING CYLINDER ITSELF, THEREFORE ARRANGEMENTS WERE TO BE MADE FOR A NEW CYLINDER WITH THE GAS COMPANY AND TO CHECK IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16974282 ↗
• MalfunctionJan 6, 2023Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER REPORTED TO OLYMPUS TECHNICAL ASSISTANCE CENTER (TAC), THAT CYLINDER HOSE W/SWITCH-OVER VALVE WAS NOT WORKING WITH PORT B. THE CUSTOMER STATED THAT THE VALVE MAY BE LEAKING. THERE WERE NO REPORTS OF PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16113778 ↗
• MalfunctionNov 22, 2022Gas/Air Leak; Gas/Air Leak

  A BIOMEDICAL ENGINEER REPORTED TO OLYMPUS, THE CYLINDER HOSE WITH SWITCH-OVER VALVE WAS LEAKING GAS. THERE WAS NO REPORT OF PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15848550 ↗
• MalfunctionJul 19, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED DURING A GYNECOLOGICAL TLH SURGERY (THERAPEUTIC LAPAROSCOPIC HYSTERECTOMY), WHEN THE SURGEON WAS PNEUMOPERITONEUM WITH MIDDLE FLOW, THE ABDOMINAL PRESSURE DID NOT RISE SUFFICIENTLY COMPARED TO NORMAL. THE SURGEON THEN SWITCHED TO HIGH FLOW , NO ABNORMALITY FOUND IN THE UHI-4 DEVICE DISPLAY, THE ABDOMINAL PRESSURE INCREASED AND THE INTENDED PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. AFTER THE OPERATION, THE FACILITY STAFF INSPECTED THE EQUIPMENT AND FOUND THAT THE NUT AT THE CONNECTION WITH THE GAS CYLINDER OF THE MAJ-1985 (CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN INDEX) WAS LOOSE. THE FACILITY STAFF TIGHTENED THE NUT. THIS EVENT INCLUDES TWO (2) REPORTS: REPORT WITH PATIENT IDENTIFIER (B)(6) (UHI-4: SN: (B)(4) ) HIGH FLOW INSUFFLATION UNIT REPORT WITH PATIENT IDENTIFIER (B)(6) ((B)(4) ) CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN INDEX) THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6) ((B)(4)CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN INDEX).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15058522 ↗
• MalfunctionSep 22, 2021Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER RETURNED THE OLYMPUS CYLINDER HOSE FOR ROUTINE MAINTENANCE. THERE WAS NO COMPLAINT ALLEGED AGAINST THE DEVICE. DURING THE DEVICE EVALUATION, IT WAS DISCOVERED THAT THE UNIT FAILED THE LEAK TEST ALLOWING GAS LEAKAGE FROM THE CYLINDER. THIS REPORT IS BEING SUBMITTED TO CAPTURED THE LEAKING GAS FORM THE CYLINDER. THERE WAS NO PATIENT INVOLVEMENT; THE ISSUE WAS IDENTIFIED DURING SERVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514336 ↗
• MalfunctionSep 16, 2021Component Missing; Component Missing

  ADDITIONAL INFORMATION REGARDING THIS EVENT WAS OBTAINED FROM THE USER FACILITY. THE SUBJECT DEVICE FAILED DURING A LAPAROSCOPIC CHOLECYSTECTOMY WHEN THE CO2 WAS DELETED AND THE TANK NEEDED TO BE SWITCHED OUT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SUBJECT DEVICE. THE DESIGN OF THE DEVICE ALLOWS THE USE OF ANOTHER HOSE. THE USER FACILITY SWITCHED TO HOSE B TO FINISH OUT THE PROCEDURE AND MANUALLY SWITCH OUT THE TANK. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12485629 ↗
• MalfunctionAug 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ASSET CYLINDER HOSE WITH A SWITCH-OVER VALVE (PIN-INDEX) WAS RETURNED TO THE SERVICE CENTER. THERE WAS NO REPORTED ALLEGATION OF ANY MALFUNCTION ASSOCIATED WITH THE DEVICE. UPON INSPECTION AND TESTING, THE UNIT WAS FOUND TO HAVE TWO MISSING "O-RINGS" FROM THE GAS HOSE. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12351926 ↗
• MalfunctionJan 26, 2021Mechanical Problem; Mechanical Problem

  AN OLYMPUS REPRESENTATIVE CALLED IN STATING THE CUSTOMER HAD SEVERAL MAJ-1985 CYLINDER HOSES MISSING THE O-RING AND CENTRAL PIN. THERE WAS NO CONSEQUENCE OR IMPACT TO PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11228840 ↗
• MalfunctionJan 25, 2021Gas/Air Leak; Gas/Air Leak

  THE CUSTOMER CONTACTED OLYMPUS TO REPORT THE DEVICE WAS LEAKING CARBON DIOXIDE, AND THEY NOTICED THE O-RING STOPPER BROKE OFF AND NEEDED REPLACEMENT. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11223868 ↗
• InjuryDec 3, 2019Gas/Air Leak; Gas/Air Leak

  THE USER REPLACED THE O-RING OF THE SUBJECT MAJ-1985. DURING THE UNSPECIFIED PROCEDURE WITH THE SUBJECT DEVICE, CO2 LEAKED FROM THE SUBJECT DEVICE. WHEN THE NURSE TOUCHED THE CO2 CYLINDER SIDE OF THE SUBJECT DEVICE FOR RECONNECT THE SUBJECT DEVICE, THE NURSE GOT COLD BURN. THE LOCAL SERVICE ENGINEER OF OLYMPUS KEYMED LTD. (OKM) REPORTED THE FOLLOWING. THERE WAS NO SERIOUS PROBLEM OF THE INJURED NURSE. THE LOCAL SERVICE ENGINEER CHECKED THE SUBJECT DEVICE AT THE FACILITY AND FOUND THAT THE REPORTED PHENOMENON (CO2 LEAK) WAS REPRODUCED, FURTHERMORE THE INCORRECT O-RING (NON-OLYMPUS) WAS FITTED TO THE YOKE (CONNECTOR FOR GAS CYLINDER) OF THE SUBJECT DEVICE. THE LOCAL SERVICE ENGINEER REPLACED THE INCORRECT O-RING OF THE SUBJECT DEVICE TO THE CORRECT O-RING DESIGNATED BY OLYMPUS, THEN THE SUBJECT DEVICE FUNCTIONED WITHOUT ANY PROBLEM. THE LOCAL SERVICE ENGINEER ADVISED THE FACILITY THAT THE CORRECT O-RING DESIGNATED BY OLYMPUS SHOULD BE USED. THERE WAS NO REPORT OF THE PATIENT INJURY OTHER THAN ABOVE.

  Patient problems: Burn(s)

  MAUDE report 9400699 ↗