Hercules G31927Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00827002319271), received between Apr 26, 2016 and Sep 29, 2026 — classified as 4 injuries, 70 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (35 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938347 ↗
• MalfunctionJul 27, 2026Material Rupture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50039261 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  DURING AN ENDOSCOPIC PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] WHEN THEY GOT TO 20 [ATM], THE BALLOON BURST AT THE DISTAL END. THEY FINISHED THE PROCEDURE BY REMOVING THE SCOPE AND BALLOON AND USED ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24433394 ↗
• MalfunctionFeb 24, 2026Fluid/Blood Leak

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON POPPED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24431820 ↗
• MalfunctionDec 12, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON BROKE AT 19 MM, STAGE 2 [LEAKAGE]. NO BALLOON MATERIAL SEPARATED FROM THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23788727 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON POPPED AT ABOUT 4 ATM WHEN INFLATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897855 ↗
• MalfunctionAug 26, 2025Material Rupture; Material Rupture

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON POPPED AT ABOUT 4 ATM WHEN INFLATED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897775 ↗
• MalfunctionAug 26, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGEAL ENDOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON POPPED AT ABOUT 4 ATM WHEN INFLATED [SUBJECT OF REPORT]. DEVICE WAS EVALUATED ON 18AUG2025. APPROXIMATELY 5.5 CM OF THE BALLOON/DISTAL HAS BEEN CUT FROM THE DEVICE AND WAS NOT INCLUDED IN THE RETURN. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22897639 ↗
• MalfunctionAug 18, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN UPPER ENDOSCOPY IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] WHILE INFLATING THE BALLOON, BEFORE IT REACHED 6 ATM, THE BALLOON STARTED TO LEAK. THE BALLOON WAS REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22828034 ↗
• MalfunctionMay 9, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON POPPED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21995795 ↗
• MalfunctionMar 11, 2025Material Rupture; Material Rupture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE BALLOON POPPED DURING DILATION WHILE IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21574183 ↗
• MalfunctionSep 19, 2019Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem; Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS INTRODUCED DOWN THE ENDOSCOPE FINE. UPON THE SECOND STAGE OF INFLATION (4 ATM TO 6 ATM), THE BALLOON BURST INSIDE OF THE PATIENT. THE DEVICE WAS REMOVED FULLY INTACT, NOTHING DETACHED IN THE PATIENT. ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9088257 ↗
• MalfunctionSep 16, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON BURST INSIDE THE PATIENT. THE CUSTOMER SAYS THAT THEY DID NOT OVER-INFLATE. THEY WERE USING ANOTHER MANUFACTURERS INFLATION DEVICE. NO PART OF THE BALLOON SEPARATED INSIDE THE PATIENT SO THEY DID NOT NEED TO RETRIEVE IT. THE FOLLOWING WAS RECEIVED ON (B)(6) 2019 PER MEDWATCH MW5089773: "PT IN MPU ROOM 7 FOR EGD PROCEDURE. WE HAVE SWITCHED OUR PRODUCT TO COOK FROM BOSTON SCIENTIFIC. WE USED THE COOK BALLOON TODAY, THE 18-20 MM THROUGH SCOPE DILATOR (HURRICANE IS THE SAME I BELIEVE). INFLATED 18MM IN STRICTURE AND HELD FOR 60 SEC THEN WENT UP TO 19MM AND THEN BALLOON RUPTURED WHEN WE WENT UP TO 20 MM MARK AFTER ABOUT 10 SEC. HAD TO REPEAT THE DILATION, CUT THE BALLOON AND REDO. THIS ADDED EXTRA TIME AS WELL AS EXTRA COST WHEN GOING THROUGH 2 BALLOONS INSTEAD OF 1. DURING PROCEDURE BALLOON WAS INFLATED AS DIRECTED BY PHYSICIAN. STAFF APPLIED NEGATIVE PRESSURE TO BALLOON AS INSTRUCTED, INFLATED TO DESIRED AND RECOMMENDED VOLUME. BALLOON WAS INITIATED TO 18 (4 PRESSURE), 19 (5 PRESSURE), 20 (6 PRESSURE). INFLATION WAS WITH THE BIG60 DEVICE AND WE INFLATED TO ATMOSPHERIC PRESSURE. N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9071457 ↗
• MalfunctionSep 13, 2019Burst Container or Vessel; Burst Container or Vessel

  AS INITIALLY REPORTED TO CUSTOMER RELATIONS: DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS INFLATED HALF WAY AND THE BALLOON BURST. NOTHING DETACHED IN THE PATIENT AND THE DEVICE WAS REMOVED INTACT. ANOTHER BALLOON WAS USED TO CONTINUE THE PROCEDURE WITH NO FURTHER COMPLICATIONS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9046404 ↗
• MalfunctionSep 6, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THERE WAS A SITUATION DURING DILATION PROCEDURE WHERE THE BALLOON BURST WHILE IN SITU [SIC] IN THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8972470 ↗
• MalfunctionJul 26, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS NOT INFLATING. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 03-JUL-2019 AND A LEAK WAS SEEN FROM A HOLE IN THE MIDDLE OF THE BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8831354 ↗
• InjuryJul 10, 2019Burst Container or Vessel; Fluid/Blood Leak; Material Separation; Burst Container or Vessel; Fluid/Blood Leak; Material Separation

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON BURST DURING THE PROCEDURE. THE DEVICE WAS EVALUATED ON (B)(6) 2019. THE BALLOON MATERIAL HAD DETACHED FROM THE REST OF THE BALLOON. THE DETACHED PORTION INCLUDED THE BALLOON TIP. THE CANNULA USED TO ASSIST WITH DEFLATION HAD ALSO DETACHED AND WAS RETURNED KINKED IN ONE LOCATION. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: THE USER INFLATED THE BALLOON TO 18 MM AND THEN ATTEMPTED TO INFLATE THE BALLOON TO 20 MM WHEN IT POPPED. AS THE USER WAS ATTEMPTING TO REMOVE THE BALLOON FROM THE ENDOSCOPE IN THE PATIENT, THE BALLOON DETACHED. AFTER THEY REMOVED THE DEVICE FROM THE ENDOSCOPE, THEY THEN REMOVED THE DETACHED PORTION FROM THE PATIENT WITH A SNARE. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT REQUIRED REMOVAL OF THE DETACHED PORTION OF THE BALLOON WITH A SNARE DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8777885 ↗
• MalfunctionJul 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE CUSTOMER HAD A BALLOON THAT WOULD NOT INFLATE. UPON INSPECTION, OUTSIDE THE PATIENT, THEY NOTED A HOLE IN THE SIDE OF THE BALLOON. THERE WAS NO HARM CAUSED TO THE PATIENT AND A DIFFERENT BALLOON WAS UTILIZED TO PROVIDE TREATMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8748593 ↗
• MalfunctionMay 10, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE DEVICE WAS USED SUCCESSFULLY; HOWEVER, WHEN REMOVING THE BALLOON, THE BALLOON WOULD NOT COME OUT OF THE ENDOSCOPE. THE ENDOSCOPE AND THE BALLOON WERE REMOVED AS A UNIT. THE BALLOON WAS EVENTUALLY REMOVED, OUTSIDE OF THE PATIENT'S BODY, FROM THE ENDOSCOPE. THE BALLOON WAS INFLATED AS A TEST OUTSIDE OF THE PATIENT'S BODY AND THE BALLOON BURST [SUBJECT OF THIS REPORT]. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601334 ↗
• MalfunctionApr 30, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE DEVICE DID NOT PERFORM PROPERLY. [THE DEVICE] HAD THREE (3) HOLES IN THE BALLOON. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8566528 ↗
• MalfunctionApr 5, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. AFTER REACHING THE FINAL DIAMETER (20 MM) AND LEVEL OF PRESSURE (6 ATM), DURING DILATION, THE BALLOON SUDDENLY BURST. THE DEVICE WAS TAKEN OUT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487218 ↗
• MalfunctionMar 7, 2019Burst Container or Vessel; Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. ON THE SECOND INFLATION, THE BALLOON BURST. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8398688 ↗
• MalfunctionMar 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON LEAKED TOWARD THE DISTAL TIP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382631 ↗
• MalfunctionMar 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON LEAKED TOWARD THE DISTAL TIP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382629 ↗
• MalfunctionMar 1, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON LEAKED TOWARD THE DISTAL TIP. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382628 ↗