OLYMPUS EndoTherapy™ Inflation Device for Endoscopic Balloon Dilation QL6015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00856877002537), received between Feb 4, 2019 and Sep 11, 2023 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2023Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS BEING USED DURING A THERAPEUTIC ESOPHAGEAL DILATATION PROCEDURE. IT WAS PRIMED WITH STERILE WATER TO THE FILL LINE AND ATTACHED TO A NON-OLYMPUS CRE FIXED WIRE BALLOON IN 12 MILLIMETER (MM)/13.5MM/15MM SIZE. UPON DILATION, IT WAS NOTED AFTER THE THIRD STRETCH THAT THE BALLOON WOULD NO LONGER INFLATE. THE BALLOON WAS DEFLATED AND REMOVED. A NEW BALLOON IN 12MM/13.5MM/15MM SIZE WAS REINSERTED AND UPON INFLATION TO 13.5MM, IT LOST PRESSURE AND THE PATIENT FELT THE BALLOON POP. REPORTEDLY, THE PATIENT DID NOT EXPERIENCE ANY PAIN. THE BALLOON WAS IMMEDIATELY REMOVED AND WAS NOTED TO HAVE BURST. THERE WERE NO RETAINED FRAGMENTS FROM THE BALLOON BURSTING. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PROCEDURE WAS DELAYED FOR LESS THAN 10-15 MINUTES BECAUSE THEY HAD TO USE MULTIPLE BALLOONS AND MULTIPLE INFLATION DEVICES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. RELATED REPORTS ARE BEING SUBMITTED ON THE MEDWATCH WITH PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725782 ↗
• MalfunctionSep 11, 2023Inflation Problem; Inflation Problem

  THE CUSTOMER REPORTED THAT THE SUBJECT DEVICE WAS BEING USED DURING A THERAPEUTIC ESOPHAGEAL DILATATION PROCEDURE. IT WAS PRIMED WITH STERILE WATER TO THE FILL LINE AND ATTACHED TO A NON-OLYMPUS CRE FIXED WIRE BALLOON IN 12 MILLIMETER (MM)/13.5MM/15MM SIZE. UPON DILATION, IT WAS NOTED AFTER THE THIRD STRETCH THAT THE BALLOON WOULD NO LONGER INFLATE. THE BALLOON WAS DEFLATED AND REMOVED. A NEW BALLOON IN 12MM/13.5MM/15MM SIZE WAS REINSERTED AND UPON INFLATION TO 13.5MM, IT LOST PRESSURE AND THE PATIENT FELT THE BALLOON POP. REPORTEDLY, THE PATIENT DID NOT EXPERIENCE ANY PAIN. THE BALLOON WAS IMMEDIATELY REMOVED AND WAS NOTED TO HAVE BURST. THERE WERE NO RETAINED FRAGMENTS FROM THE BALLOON BURSTING. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE PROCEDURE WAS DELAYED FOR LESS THAN 10-15 MINUTES BECAUSE THEY HAD TO USE MULTIPLE BALLOONS AND MULTIPLE INFLATION DEVICES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. RELATED REPORTS ARE BEING SUBMITTED ON THE MEDWATCH WITH PATIENT IDENTIFIER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17725623 ↗
• MalfunctionJul 27, 2023Inflation Problem; Inflation Problem

  THE PATIENT DID NOT EXPERIENCE ANY PAIN BUT DID FEEL THE BALLOON POP. THERE WERE NO RETAINED FRAGMENTS FROM THE BALLOON BURSTING. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (ESOPHAGEAL DILATATION) AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A 10¿15-MINUTE DELAY TO SWITCH DEVICES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT IS REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) ¿ INFLATION DEVICE (1/4). (B)(6) ¿ INFLATION DEVICE (2/4). (B)(6) - INFLATION DEVICE (3/4). (B)(6) - INFLATION DEVICE (4/4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406601 ↗
• MalfunctionJul 27, 2023Inflation Problem; Inflation Problem

  THE PATIENT DID NOT EXPERIENCE ANY PAIN BUT DID FEEL THE BALLOON POP. THERE WERE NO RETAINED FRAGMENTS FROM THE BALLOON BURSTING. THE EVENT OCCURRED DURING THE THERAPEUTIC PROCEDURE (ESOPHAGEAL DILATATION) AND WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS A 10¿15-MINUTE DELAY TO SWITCH DEVICES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT IS REPORTED UNDER THE FOLLOWING PATIENT IDENTIFIERS: (B)(6) - INFLATION DEVICE (1/4) (B)(6) - INFLATION DEVICE (2/4) (B)(6) INFLATION DEVICE (3/4) (B)(6)- INFLATION DEVICE (4/4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17406577 ↗
• MalfunctionMar 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPANY REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE. ISSUE REPORTED WAS THAT THE ¿ITEMS GOT WET". THE ISSUE FOUND DURING RECEIPT INSPECTION. THE REPORTED EVENT INVOLVED THE SAME MODEL WITH THE SAME LOT (6 DEVICES) IN TOTAL. THIS REPORT IS BEING SUBMITTED DUE TO REPORT OF "ITEMS GOT WET" (DAMAGED PACKAGING - STERILITY COMPROMISED). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED. THIS EVENT INCLUDES SIX (6) REPORTS TO CAPTURE THE SIX DEVICES OF THE SAME LOT AND MODEL REPORTED WITH ISSUE OF "ITEMS GOT WET ". REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129 .REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. THIS REPORT IS FOR PATIENT IDENTIFIER: (B)(6),LOT 96379129.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625175 ↗
• MalfunctionMar 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPANY REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE. ISSUE REPORTED WAS THAT THE ¿ITEMS GOT WET". THE ISSUE FOUND DURING RECEIPT INSPECTION. THE REPORTED EVENT INVOLVED THE SAME MODEL WITH THE SAME LOT (6 DEVICES) IN TOTAL. THIS REPORT IS BEING SUBMITTED DUE TO REPORT OF "ITEMS GOT WET" (DAMAGED PACKAGING - STERILITY COMPROMISED). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED. THIS EVENT INCLUDES SIX (6) REPORTS TO CAPTURE THE SIX DEVICES OF THE SAME LOT AND MODEL REPORTED WITH ISSUE OF "ITEMS GOT WET ". REPORT WITH PATIENT IDENTIFIER (B)(6) -MAJ-1740 LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6) -MAJ-1740 LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6) - MAJ-1740 LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6) - MAJ-1740 LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6) -MAJ-1740 LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6) - MAJ-1740 LOT 96379129. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6)- MAJ-1740 LOT 96379129.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625153 ↗
• MalfunctionMar 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPANY REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE. ISSUE REPORTED WAS THAT THE ¿ITEMS GOT WET". THE ISSUE FOUND DURING RECEIPT INSPECTION. THE REPORTED EVENT INVOLVED THE SAME MODEL WITH THE SAME LOT (6 DEVICES) IN TOTAL. THIS REPORT IS BEING SUBMITTED DUE TO REPORT OF "ITEMS GOT WET" (DAMAGED PACKAGING - STERILITY COMPROMISED). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED. THIS EVENT INCLUDES SIX (6) REPORTS TO CAPTURE THE SIX DEVICES OF THE SAME LOT AND MODEL REPORTED WITH ISSUE OF "ITEMS GOT WET ". REPORT WITH PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129, REPORT WITH PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129, REPORT WITH PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129, REPORT WITH PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129, REPORT WITH PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129, REPORT WITH PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129. THIS REPORT IS FOR PATIENT IDENTIFIER: (B)(6), MAJ-1740, LOT: 96379129.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625127 ↗
• MalfunctionMar 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPANY REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE. ISSUE REPORTED WAS THAT THE ¿ITEMS GOT WET". THE ISSUE FOUND DURING RECEIPT INSPECTION. THE REPORTED EVENT INVOLVED THE SAME MODEL WITH THE SAME LOT (6 DEVICES) IN TOTAL. THIS REPORT IS BEING SUBMITTED DUE TO REPORT OF "ITEMS GOT WET" (DAMAGED PACKAGING - STERILITY COMPROMISED). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED. THIS EVENT INCLUDES SIX (6) REPORTS TO CAPTURE THE SIX DEVICES OF THE SAME LOT AND MODEL REPORTED WITH ISSUE OF "ITEMS GOT WET ". REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6), LOT 96379129.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625110 ↗
• MalfunctionMar 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPANY REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE. ISSUE REPORTED WAS THAT THE ¿ITEMS GOT WET". THE ISSUE FOUND DURING RECEIPT INSPECTION. THE REPORTED EVENT INVOLVED THE SAME MODEL WITH THE SAME LOT (6 DEVICES) IN TOTAL. THIS REPORT IS BEING SUBMITTED DUE TO REPORT OF "ITEMS GOT WET" (DAMAGED PACKAGING - STERILITY COMPROMISED). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED. THIS EVENT INCLUDES SIX (6) REPORTS TO CAPTURE THE SIX DEVICES OF THE SAME LOT AND MODEL REPORTED WITH ISSUE OF "ITEMS GOT WET ". REPORT WITH PATIENT IDENTIFIER (B)(6): MAJ-1740, LOT 96379129, REPORT WITH PATIENT IDENTIFIER (B)(6): MAJ-1740, LOT 96379129, REPORT WITH PATIENT IDENTIFIER (B)(6): MAJ-1740, LOT 96379129, REPORT WITH PATIENT IDENTIFIER (B)(6): MAJ-1740, LOT 96379129, REPORT WITH PATIENT IDENTIFIER (B)(6): MAJ-1740, LOT 96379129, REPORT WITH PATIENT IDENTIFIER (B)(6): MAJ-1740, LOT 96379129. THIS REPORT IS FOR PATIENT IDENTIFIER (B)(6): MAJ-1740 LOT 96379129.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625079 ↗
• MalfunctionMar 27, 2023Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  COMPANY REPRESENTATIVE REPORTED AN OUT OF BOX FAILURE. ISSUE REPORTED WAS THAT THE ¿ITEMS GOT WET". THE ISSUE FOUND DURING RECEIPT INSPECTION. THE REPORTED EVENT INVOLVED THE SAME MODEL WITH THE SAME LOT (6 DEVICES) IN TOTAL. THIS REPORT IS BEING SUBMITTED DUE TO REPORT OF "ITEMS GOT WET" (DAMAGED PACKAGING - STERILITY COMPROMISED). THERE WAS NO PATIENT INVOLVEMENT ON THIS REPORTED EVENT. NO HARM WAS REPORTED, NO USER INJURY REPORTED. THIS EVENT INCLUDES SIX (6) REPORTS TO CAPTURE THE SIX DEVICES OF THE SAME LOT AND MODEL REPORTED WITH ISSUE OF "ITEMS GOT WET ". REPORT WITH PATIENT IDENTIFIER (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER : (B)(6), LOT 96379129 REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER: (B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER: ((B)(6), LOT 96379129. REPORT WITH PATIENT IDENTIFIER : (B)(6), LOT 96379129. THIS REPORT IS FOR PATIENT IDENTIFIER:(B)(6), LOT 96379129.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16625020 ↗
• MalfunctionSep 9, 2021Output Problem; Output Problem

  AS REPORTED, THE DEVICE MAJ-1740 DID NOT SHOW THE CORRESPONDING CALIBRATION. THE PRESSURE DIAL WOULD NOT MOVE DESPITE PRESSURE APPLIED. THE ISSUE OCCURRED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) THERAPEUTIC PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY, NO USER INJURY REPORTED DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451427 ↗
• MalfunctionFeb 4, 2019Leak/Splash

  PHYSICIAN WAS DOING A BALLOON DILATION OF FIBROTIC STRICTURE ABOUT 10 CM INTO THE TERMINAL ILEUM THAT THE COLONOSCOPE COULD NOT PASS. A COLONIC BALLOON WAS INTRODUCED THROUGH SCOPE'S ACCESSORY CHANNEL AND USED TO DILATE THE STRICTURE UP TO 11 MM. DURING THE DILATION THE BALLOON FAILED AND WATER THAT WAS USED TO INFLATE LEAKED FROM BALLOON. A NEW BALLOON WAS OBTAINED AND THE DILATION WAS PERFORMED WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8300929 ↗