Hercules G48732Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00827002487321), received between Apr 26, 2016 and Sep 15, 2025 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (13 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2025Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON BROKE DURING A DILATION OF A PATIENT'S ESOPHAGUS. WHILE THE NURSE WAS INFLATING THE BALLOON FROM 16.5 TO 18, THE PRESSURE GAUGE DROPPED AND THE PHYSICIAN FELT A POP. THE NURSE ATTEMPTED TO PULL THE WATER OUT OF THE BALLOON SYRINGE AND ONLY 10MLS OF WATER CAME OUT. THERE WAS A TEAR NOTED BY THE PHYSICIAN, THE BALLOON WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED. THE PATIENT RECOVERED WITHOUT DIFFICULTY. 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 23057966 ↗
• MalfunctionJun 8, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING A TRANSENDOSCOPIC ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS REPORTED [THAT] THE USER ATTEMPTED TO INFLATE THE BALLOON AT TARGET SITE OF ESOPHAGUS, BUT IT DIDN'T INFLATE. HE OBSERVED THAT THE SALINE WITH CONTRAST MEDIUM WAS LEAKED FROM THE BALLOON [SUBJECT OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 17091456 ↗
• MalfunctionAug 19, 2021Material Rupture; Material Rupture

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON POPPED WHEN THEY WERE INFLATING TO THE LAST MEASUREMENT. AT 18MM, IT POPPED IN A CIRCUMFERENTIAL BURST. ONCE THE BALLOON POPPED, THEY REMOVED ALL THE BALLOON FROM THE PATIENT. NO INJURY OCCURRED. USER ABORTED THE PROCEDURE AT THAT POINT. 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 12341110 ↗
• MalfunctionAug 3, 2021Material Puncture/Hole; Material Puncture/Hole

  DURING AN ENDOSCOPIC BALLOON DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. AT THE END OF THE PROCEDURE, THE PHYSICIAN TRIED TO REMOVE THE REPORTED BALLOON FROM THE ENDOSCOPE ACCESSORY CHANNEL, BUT HE COULD NOT REMOVE THE REPORTED DEVICE. THEREFORE, HE TOOK BOTH THE REPORTED DEVICE AND THE ENDOSCOPE OUT OF THE PATIENT'S BODY. THE PHYSICIAN WAS ABLE TO DEFLATE AND REMOVE THE REPORTED BALLOON OUTSIDE THE BODY. THIS WAS NOT REPORTABLE AT THE TIME. THE DEVICE WAS RETURNED ON 09-JUL-2021 AND IT WAS NOTED THAT THERE WAS A HOLE IN THE BALLOON. [SUBJECT OF 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 12266504 ↗
• MalfunctionDec 29, 2020Fluid/Blood Leak; Fluid/Blood Leak

  PRIOR TO AN ENDOSCOPIC DILATION PROCEDURE, THE PHYSICIAN PREPARED TWO (2) COOK HERCULES 3 STAGE BALLOON ESOPHAGEALS. THE BALLOONS HAD SMALL HOLES IN THEM. PER THE USER, THE PACKAGING WAS INTACT AND THE ITEMS WERE HANDLED APPROPRIATELY. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 11089292 ↗
• MalfunctionNov 24, 2020Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN SELECTED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE PHYSICIAN INFLATED THE BALLOON DURING THE PROCEDURE. AT 17 1/2MM THE BALLOON LEAKED FROM THE MIDDLE. THE PHYSICIAN DEFLATED AND REMOVED THE BALLOON FROM THE PATIENT. SINCE THE PHYSICIAN HAD ACQUIRED SUFFICIENT DILATION, NO ADDITIONAL DEVICES WERE USED AND THE PROCEDURE WAS COMPLETED. 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 10897214 ↗
• MalfunctionNov 16, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS DAMAGED IN THE SECOND PASS AND IT WAS NOT AT ALL COMING OUT OF THE SCOPE TIP IT WAS VERY DIFFICULT TO PUSH AND MEANWHILE THE CATHETER WAS KINKING. THE BALLOON GOT RUPTURED AND THERE WAS LEAKAGE. ADDITIONAL INFORMATION RECEIVED ON 26-OCTOBER-2020 STATED THAT THE PATIENT HAD A DILATION IN THE ESOPHAGUS DUE TO A POST-SURGERY ANASTOMOTIC STRICTURE. A NEW BALLOON WAS OPENED AND PASSED THROUGH THE WORKING CHANNEL TO DILATE THE STRICTURE TO 15 MM AND THE BALLOON WAS TAKEN BACK INSIDE. AFTER COMPLETE DEFLATION OF THE BALLOON USING THE SUCTION CATHETER, [IT] PASSED INSIDE THE SCOPE. THE USER TRIED TO RE-DILATE [THE STRICTURE] COMPLETELY UP TO 16.5 MM, BUT THE BALLOON DIDN'T COME OUT AND A LOT OF RESISTANCE WAS THERE. WHILE PUSHING, THE CATHETER SEEMED KINKED AND WOULD NOT COME OUT. CLARIFICATION RECEIVED ON 13-NOVEMBER-2020 STATES THAT A NEW BALLOON WAS OPENED AND DEFLATED COMPLETELY AND PASSED THROUGH THE ENDOSCOPE. THE USER INFLATED THE BALLOON UP TO 15 MM AND PASSED THE ENDOSCOPE THROUGH THE ANASTOMOTIC STRUCTURE AND DEFLATED THE BALLOON TO TAKE IT BACK INTO THE ENDOSCOPE AN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843585 ↗
• MalfunctionSep 22, 2020Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WOULD NOT INFLATE AT ALL. A SECOND BALLOON WAS PLACED DOWN THE SCOPE, AND THE FACILITY WAS NOT CONFIDENT IT WOULD INFLATE. A THIRD BALLOON WAS OPENED, AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 02-SEP-2020, AND A LEAK WAS OBSERVED FROM A PINHOLE NEAR THE MIDDLE OF THE BALLOON MATERIAL. 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 10568203 ↗
• MalfunctionAug 21, 2020Fluid/Blood Leak; Fluid/Blood Leak

  THIS CORRECTION FOLLOW UP REPORT IS BEING SUBMITTED TO CANCEL THE INITIAL REPORT SUBMITTED RELATING TO THIS EVENT. REFERENCE THE ADDITIONAL MANUFACTURE NARRATIVE SECTION FOR THIS JUSTIFICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10438672 ↗
• MalfunctionMar 26, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON WAS INFLATED AND DEFLATED TWICE, THEN MOVED TO ANOTHER POSITION IN THE ESOPHAGUS. THE BALLOON WAS INFLATED AGAIN TO 15 MM AND WHILE INFLATING TO 18 MM THE BALLOON RUPTURED. 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 9884297 ↗
• MalfunctionMar 17, 2020Material Rupture; Material Rupture

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON EXPLODED PRIOR TO REACHING THE MAXIMUM LIMIT OF DILATION. 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 9841827 ↗
• MalfunctionFeb 28, 2020Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON HAD A HOLE AND THERE WAS LEAKAGE. 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 9770868 ↗
• MalfunctionFeb 7, 2020Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS INFLATED ONCE AND DEFLATED ONCE AND IT WAS NOTED TO BE LEAKING/DEFLATING, HOWEVER THE PINHOLE WAS SMALL ENOUGH IN DIAMETER THAT THE PHYSICIAN WAS ABLE 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 9680868 ↗
• MalfunctionFeb 7, 2020Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS LEAKING. ANOTHER DEVICE WAS USED TO CONTINUE DILATION 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 9680829 ↗
• MalfunctionFeb 7, 2020Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS LEAKING. ANOTHER DEVICE WAS USED TO CONTINUE DILATION 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 9680812 ↗
• MalfunctionDec 13, 2019Burst Container or Vessel; Fluid/Blood Leak; Burst Container or Vessel; Fluid/Blood Leak

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE TECHNICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WOULD NOT HOLD PRESSURE. THE TECHNICIAN NOTED IT APPEARED THERE WAS SOME WATER LEAKING OUT THE DISTAL END OF THE BALLOON. A NEW COOK HERCULES BALLOON WAS OPENED AND USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 9468314 ↗
• MalfunctionNov 22, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN UPPER ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON HAD A PIN HOLE IN IT. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 9364343 ↗
• MalfunctionOct 11, 2019Material Puncture/Hole; Material Puncture/Hole

  PRIOR TO THE PROCEDURE, THE PHYSICIAN INFLATED THE HERCULES 3 STAGE BALLOON ESOPHAGEAL TO CHECK THE CONDITION OF IT AND THEN REALIZED THE BALLOON WAS BROKEN AND THE CONTENTS SPILLED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER HERCULES 3 STAGE BALLOON ESOPHAGEAL. ON 25-SEP-2019, THE FOLLOWING INFORMATION WAS RECEIVED, "WE REVIEWED THE CASE IN ORDER TO ANSWER THE PENDING QUESTION SO, THE VIDEO WAS TAKEN AFTER THE PROCEDURE TO CHECK THE LEAKAGE, THE BALLOON WAS TRIED WITH AIR AT FIRST AND THEN THE LEAK WAS DISCOVERED ONCE THE WATER WAS PUT IN." THIS OBSERVATION WAS MADE PRIOR TO USE; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9180996 ↗
• MalfunctionAug 26, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON WAS LEAKING AND WOULD NOT HOLD INFLATION. THEY WENT DOWN THE CHANNEL OF THE ENDOSCOPE, SAW A PINHOLE LEAK ON THE BALLOON, WITHDREW BALLOON AND USED ANOTHER DEVICE TO COMPLETE 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 8931357 ↗
• MalfunctionJul 31, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. IT WAS DISCOVERED DURING USE THAT THERE WAS A PIN HOLE IN THE BALLOON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 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 Consequences Or Impact To Patient

  MAUDE report 8848261 ↗
• MalfunctionMar 12, 2019Burst Container or Vessel; Burst Container or Vessel

  IN PREPARATION FOR AN UPPER ENDOSCOPY, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THERE WAS A HOLE IN THE BALLOON. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8413825 ↗
• MalfunctionMar 8, 2019Burst Container or Vessel; Burst Container or Vessel

  THE FOLLOWING WAS INITIALLY REPORTED TO THE FDA ON 08-MAR-2019 "DURING A BALLOON DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON BURST. ON REMOVAL, IT HAD SHREDDED AND LODGED IN THE ENDOSCOPE." THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED WITH THE DEVICE ON 06-MAY-2019: "USING MULTIPLE BALLOON DILATOR TO TREAT AN ESOPHAGEAL STRICTURE, THE BALLOON INFLATED THE FIRST TIME WITH NO PROBLEM. WE RE-INFLATED IT AND IT WAS EVIDENT IT HAD BURST. WHEN WE TRIED TO REMOVE THE BALLOON IT HAD SHREDDED AND BECOME LODGED IN THE GASTROSCOPE. NO INJURY TO THE PATIENT ON THIS OCCASION." OUR ATTEMPTS TO COLLECT SPECIFIC PATIENT OUTCOME INFORMATION WERE UNSUCCESSFUL. THE MISSING PORTION OF THE BALLOON WAS NOT INCLUDED IN THE RETURN AND THE LOCATION IS UNKNOWN. BECAUSE THE COMPLAINANT STATED THAT THERE WAS NO INJURY TO THE PATIENT, WE CAN CONCLUDE THAT THIS INFORMATION DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8405068 ↗
• MalfunctionSep 24, 2018Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. PER MEDWATCH FORM 2600320000-2018-8089: "WHILE USING A DILATION BALLOON, THE EQUIPMENT FAILED TO STAY DILATED DURING THE PROCEDURE. THE [PHYSICIAN] WANTED TO MAKE SURE THE COMPANY WAS AWARE OF THE FAULTY PRODUCT." ADDITIONAL INFORMATION WAS RECEIVED ON 21-SEP-2018 THAT THE BALLOON HAD RUPTURED. ALTHOUGH A PORTION OF SPECIFIC PATIENT OUTCOME INFORMATION WAS NOT PROVIDED, THE INITIAL REPORTER SPECIFIED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901787 ↗
• MalfunctionJul 16, 2018Leak/Splash; Use of Device Problem; Leak/Splash; Use of Device Problem

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THE BALLOON OF THE CATHETER PIERCED DURING THE PROCEDURE. WHEN THE DOCTOR PUSHED THE BALLOON INTO THE ESOPHAGUS, THE NURSE INFLATED THE BALLOON. THE BALLOON DID NOT INFLATE. IT WAS PUNCTURED WHEN SHE INCREASED THE PRESSURE. THERE WAS CONTRAST IN THE ESOPHAGUS. A SECOND BALLOON [OF THE] SAME REFERENCE WAS USED WITHOUT ANY INCIDENT. THERE WERE NO CONSEQUENCES FOR THE PATIENT EXCEPT A DELAY IN CARE AND TEN (10) EXTRA MINUTES UNDER ANESTHESIA. 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 7691793 ↗
• MalfunctionFeb 23, 2018Burst Container or Vessel; Use of Device Problem; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Use of Device Problem; Improper or Incorrect Procedure or Method

  DURING A DILATION PROCEDURE, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE BALLOON ESOPHAGEAL. THERE WAS A PUNCTURE OF THE ESOPHAGEAL DILATOR BALLOON DURING INFLATION. THEY USED ANOTHER BALLOON [TO FINISH THE PROCEDURE]. THE FOLLOWING INFORMATION WAS RECEIVED ON (B)(6) 18 FROM THE COMPLAINT FORM: "WHEN THE DOCTOR PUSHED THE BALLOON INTO THE ESOPHAGUS, THE NURSE INFLATED THE BALLOON; THE BALLOON DID NOT INFLATE. [THE BALLOON] WAS PUNCTURED. WHEN SHE INCREASED THE PRESSURE, THE CONTRAST WAS IN THE ESOPHAGUS. THEY CHANGED THE BALLOON. THERE WERE NO CONSEQUENCES TO THE PATIENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293280 ↗