Hercules G51795Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 00827002517950), received between Apr 26, 2016 and Aug 28, 2026 — classified as 1 injury, 43 malfunctions.

The most frequently reported specific device problem is “Crack” (18 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50506015 ↗
• MalfunctionAug 21, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50372520 ↗
• MalfunctionAug 12, 2026Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227553 ↗
• MalfunctionJan 8, 2026Material Rupture

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE DILATION BALLOON RUPTURED [LEAKAGE], MAKING IT IMPOSSIBLE TO INFLATE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24004060 ↗
• MalfunctionDec 5, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC PROCEDURE FOR BILE DUCT STONE REMOVAL, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE USER ADVANCED THE DEVICE THROUGH THE ENDOSCOPIC WORKING CHANNEL [AND] FOUND OUT THE SHEATH CRACKED. USER TRIED TO DILATE THE DEVICE BUT COULD NOT REACH DESIRED RESULT. USER CHANGED TO A NEW DEVICE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 23728114 ↗
• MalfunctionAug 27, 2025Fluid/Blood Leak; Fluid/Blood Leak

  DURING AN ENDOSCOPIC PROCEDURE IN THE ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE BALLOON WOULD NOT ADVANCE INTO SCOPE BECAUSE THE BALLOON WAS TORN, CAUSING [USER] TO OPEN A SECOND 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 22905440 ↗
• MalfunctionApr 25, 2025Off-Label Use; Off-Label Use

  DURING AN ENDOSCOPIC PROCEDURE IN THE BILE DUCT, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS [REPORTED] THAT THE USER DETECTED THE BALLOON LEAKING ISSUE DURING USE, AND CHANGED TO ANOTHER ONE TO CONTINUE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21913313 ↗
• MalfunctionSep 9, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE USER ADVANCED THE DEVICE TO THE DESIRED POSITION AND THEN INFLATED THE BALLOON WITH WATER, WHEN THEY FOUND THAT THE BALLOON WAS LEAKING. THE USER CHANGED TO ANOTHER OF THE SAME DEVICE 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 8975767 ↗
• MalfunctionSep 6, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING AN ESOPHAGEAL BALLOON DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHEN THEY TRIED TO DILATE, THEY FOUND THAT THE BALLOON WAS BROKEN. THEY USED ANOTHER NEW PACKAGE AND THE NEW ONE WAS OKAY. 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 8972469 ↗
• MalfunctionAug 20, 2019Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. [IT WAS] IMPOSSIBLE TO PASS THE DEVICE IN THE CHANNEL OF THE ENDOSCOPE (CHANNEL GREATER THAN 2.8 MM). THEY USED ANOTHER DEVICE, SAME REFERENCE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 26-JUL-2019 AND CRACKS WERE OBSERVED IN THE CATHETER APPROXIMATELY 92 CM AND 101.5 CM FROM THE DISTAL END. 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 8912627 ↗
• MalfunctionJul 18, 2019Burst Container or Vessel; Improper or Incorrect Procedure or Method; Device-Device Incompatibility; Burst Container or Vessel; Improper or Incorrect Procedure or Method; Device-Device Incompatibility

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON BURST WHEN THE PHYSICIAN GOT TO THE SECOND MEASUREMENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019: THEY WERE DOING A DILATION IN THE ESOPHAGUS, THEY INFLATED TO 10 MM WITH NO PROBLEMS. THEY WAITED A LITTLE BEFORE TO PASS TO THE NEXT MEASUREMENT. AFTER A WHILE, THEY DEFLATED THE BALLOON AND TRIED TO INFLATE TO THE NEXT SIZE, 11 MM. THEY ONLY HAD THE INFLATION DEVICE FROM ANOTHER MANUFACTURER AND IT ONLY HAS 30 ML OF VOLUME, SO DURING THE PROCEDURE WHEN THE INFLATION DEVICE BECAME EMPTY THEY DISCONNECTED IT FROM THE BALLOON, THEN THEY FULL [FILL] AGAIN THE DEVICE, WITH A DILUTION OF CONTRAST AND WATER. THEY FINALLY CONNECTED IT AGAIN TO THE BALLOON IN ORDER TO CONTINUE WITH THE INFLATION OF THE DEVICE. WHEN THEY INFLATED THE BALLOON WITH THE SECOND SYRINGE THE BALLOON SUDDENLY BURST. AFTER THAT THEY RETRIEVED THE BALLOON [OUT] OF THE WORKING CHANNEL OF THE ENDOSCOPE AND CONTINUED WITH THE PROCEDURE WITH ANOTHER DEVICE. THEY ARE AWARE THAT THE OTHER MANUFACTURER'S DEVICE IS NOT APPROPRIATE FOR THE COOK HERCULES BALLOON. A SECTION OF THE DEVICE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8804314 ↗
• MalfunctionMay 21, 2019Burst Container or Vessel; Use of Device Problem; Burst Container or Vessel; Use of Device Problem

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON BURST WHILE [COMPLETING THE] DILATION, SPREADING THE CONTRAST MEDIUM INSIDE IT [THE ESOPHAGUS]. THE BALLOON WAS REMOVED AND IT WAS REPLACED WITH ANOTHER ONE WITH THE NEXT MEASURE. WHILE PERFORMING AN ESOPHAGOSCOPY, A ESOPHAGEAL DILATION WITH THE 10-11-12 BALLOON WAS MADE, BUT IT PRESENTED A RUPTURE, LEADING TO A CONTRAST MEDIUM SPILL. THE DOCTOR DECIDE TO REPLACE THE BALLOON WITH A 13-14-15 WITH SOME DIFFICULTIES. THERE WERE NO ADDITIONAL COMPLICATIONS WITH THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED 02-MAY-2019: A SEVEN (7) MONTHS OLD PATIENT, WHO BECAUSE OF A TUMOR, HAD SURGICAL RESECTION AND SUBSEQUENT ANASTOMOSIS WITH PROLENE SUTURES. THE ANATOMIC ALTERATION GENERATED STENOSIS AND DIMINISHED THE ESOPHAGUS LIGHT BY 99% WHICH CAUSED THE DIFFICULT ACCESS OF THE DEVICE. THE PATIENT HAD AN ALTERED ANATOMY DUE TO A PREVIOUS INTERVENTION. WHEN THE ANATOMY IS ALTERED THE DEVICE'S ACCESS IS ALWAYS HARD. THE ANATOMIC CONDITIONS OF THE PATIENT MAKE THE PRODUCT ACCESS DIFFICULT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8628599 ↗
• MalfunctionApr 18, 2019Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE CATHETER WAS PUNCTURED [CATHETER CRACKED]. THE BALLOON COULD NOT INFLATE. 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 8527818 ↗
• InjuryApr 5, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THEY TOOK THE BALLOON TO DILATE AND IT WOULD NOT BLOW UP. WATER WAS SEEN IN THE ESOPHAGUS AND THE PATIENT ASPIRATED. THEY ABORTED THE PROCEDURE AND BAGGED [MANUAL VENTILATION] THE PATIENT, BECAUSE THE PATIENT DESATURATED [BLOOD OXYGEN LEVEL DROPPED]. THEY PERFORMED X-RAYS AND THE PATIENT WAS ADMITTED [TO THE HOSPITAL]. THE X-RAYS CONFIRMED ASPIRATION. ADDITIONAL INFORMATION WAS RECEIVED ON 21-MAR-2019: THE OXYGEN SATURATION OF THE PATIENT IS UNKNOWN, BUT IT WAS LOW ENOUGH FOR THE ANESTHESIA PROVIDER TO USE BAG SUPPORT DURING THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED MANUAL VENTILATION, X-RAY, AND HOSPITAL ADMISSION DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT ASPIRATED DUE TO THIS OCCURRENCE.

  Patient problems: Aspiration/Inhalation

  MAUDE report 8488542 ↗
• MalfunctionApr 5, 2019Fluid/Blood Leak; Off-Label Use; Fluid/Blood Leak; Off-Label Use

  THIS CORRECTION FOLLOW UP REPORT IS BEING SENT TO CANCEL THE INITIAL REPORT SUBMITTED RELATED TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8487276 ↗
• MalfunctionApr 3, 2019Crack; Material Puncture/Hole; Crack; Material Puncture/Hole

  IN PREPARATION FOR AN ESOPHAGEAL DILATION PROCEDURE ON AN ANIMAL PATIENT, THE PHYSICIAN CHOSE A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. [THERE WAS] A SMALL PINHOLE IN THE PRODUCT. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER ON 27-FEB-2019: WHEN SHE OPENED UP THE PACKAGE, SHE NOTICED A CRACK IN THE BLUE WIRE [CATHETER] AND A PIN-SIZE HOLE IN THE TUBING. SHE DID NOT NEED TO TEST IT PRIOR TO USE, SINCE THE HOLE AND CRACK WERE VISIBLE. THE DOCTOR WAS GOING TO USE IT FOR AN ESOPHAGEAL STRICTURE. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8480593 ↗
• MalfunctionApr 1, 2019Fluid/Blood Leak; Off-Label Use; Fluid/Blood Leak; Off-Label Use

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. AT THAT TIME THE PHYSICIAN ATTEMPTED TO PERFORM A SPHINCTEROPLASTY AND UTILIZED THE HERCULES BALLOON TO DILATE THE PAPILLA [OFF LABEL USE]. DURING THE DILATION, THE HERCULES BALLOON DID NOT HOLD PRESSURE. THE COOK CLINICAL SPECIALIST RECOMMENDED REMOVING THE BALLOON. THE BALLOON WAS REMOVED AND TESTED OUTSIDE OF THE PATIENT'S BODY. IT WAS NOTED THAT THE BALLOON WOULD NOT HOLD PRESSURE AND LEAKED FLUID. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SECOND HERCULES 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 8471142 ↗
• MalfunctionMar 22, 2019Crack; Crack

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. [THE USER WAS] DILATING A SMALL STRICTURE IN THE ESOPHAGUS. [THEY] PERFORMED A STAGED DILATION AT 10 MM AND 11 MM. WHEN THE BALLOON WAS INFLATED TO 12 MM, THE BALLOON STARTED TO LOSE PRESSURE AND THE PHYSICIAN NOTICED THE CATHETER FELT FUNNY AND IT WAS REMOVED FROM THE ENDOSCOPE. THE CATHETER WAS NOTED TO BE BROKEN. THE NURSE STATED THE CATHETER WAS NOT KINKED, WHEN REMOVED FROM THE PACKAGE, AND STATES THAT SHE PARTIALLY REMOVED THE WIRE AFTER THE BROKEN BALLOON WAS REMOVED FROM THE ENDOSCOPE. SHE SAID THE WIRE WAS LEFT IN PLACE DURING THE PROCEDURE. A NEW BALLOON OF THE SAME TYPE WAS OPENED TO FINISH 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 8443215 ↗
• MalfunctionFeb 26, 2019Crack; Crack

  IN PREPARATION FOR A PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHEN THEY OPENED THE PRODUCT, THE CATHETER WAS BROKEN. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8371938 ↗
• MalfunctionFeb 15, 2019Crack; Crack

  DURING AN ENDOSCOPIC DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. DURING INSERTION OF THE CATHETER INTO THE COLONOSCOPE, THE BLUE CATHETER BROKE AT THREE (3) POINTS. THE CUSTOMER CLAIMS THAT IT WAS DUE TO THE STIFFNESS OF THE CATHETER. THEY FINISHED THE PROCEDURE WITH THE ANOTHER MANUFACTURER'S 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 8345427 ↗
• MalfunctionOct 29, 2018Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem; Fluid/Blood Leak; Material Puncture/Hole; Use of Device Problem

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THEY PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DOCTOR AND ASSISTANT REPORTED AT THE MOMENT OF BLOWING THE [BALLOON], THEY REALIZED THAT THE [BALLOON] WAS MISSING ON THE FIRST ATTEMPT. [THERE WAS] NO PATIENT COMPLICATION. THE DOCTOR DECIDED TO USE A NEW HERCULES BALLOON. THEY USED STERILE WATER; THEY USED THE QID QUANTUM [INFLATION] DEVICE. [THE BALLOON] WAS INFLATED WITH THE RECOMMENDED MEASURES OF THE MANUAL. 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 8014311 ↗
• MalfunctionOct 16, 2018Burst Container or Vessel; Use of Device Problem; Volume Accuracy Problem; Improper or Incorrect Procedure or Method; Burst Container or Vessel; Use of Device Problem; Volume Accuracy Problem; Improper or Incorrect Procedure or Method

  THE FOLLOWING WAS INITIALLY PROVIDED ON(B)(6) 2018, DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DILATATION BALLOON PUNCTURED DURING THE PROCEDURE. ANOTHER DEVICE WAS USED [TO COMPLETE THE PROCEDURE]. [IT WAS] IMPOSSIBLE TO TEST THE BALLOON BEFORE USE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED (B)(6) 2018, 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; THE CONTRAST WAS IN ESOPHAGUS. THEY CHANGED THE BALLOON. [THERE WERE] NO CONSEQUENCES FOR 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; No Known Impact Or Consequence To Patient

  MAUDE report 7971332 ↗
• MalfunctionOct 5, 2018Leak/Splash; Leak/Splash

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON COULD NOT BE INFLATED AFTER [BEING] ADVANCED TO THE DESIRED POSITION. THE USER RETRACTED THE DEVICE FROM THE ENDOSCOPE AND FOUND OUT THE BALLOON WAS BROKEN. 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 7938089 ↗
• MalfunctionSep 21, 2018Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICE WAS USED FOR DILATION OF THE STENOSED SITE IN THE LARGE INTESTINE. AN OLYMPUS ENDOSCOPE WAS INSERTED INTO THE PATIENT FIRST. WHEN THE PHYSICIAN INSERTED THE DEVICE THROUGH THE ENDOSCOPE CHANNEL, THE CATHETER BECAME KINKED. THEREFORE, ANOTHER DEVICE WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED FOR EVALUATION ON 27-AUG-2018 AND WAS FOUND TO HAVE TWO (2) CRACKS IN THE CATHETER. 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 7897796 ↗
• MalfunctionAug 3, 2018Crack; Use of Device Problem; Improper or Incorrect Procedure or Method; Crack; Use of Device Problem; Improper or Incorrect Procedure or Method

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. AFTER ADVANCING A WIRE GUIDE THROUGH THE TARGET SITE, THE DEVICE WAS ADVANCED OVER THE WIRE GUIDE FOR DILATION OF THE DIGESTIVE TRACT. HOWEVER, BECAUSE THE STENOSIS WAS SO SEVERE, THE SHAFT [CATHETER] BECAME BENT WHILE THE USER WAS ADVANCING THE DEVICE AND INFLATING THE BALLOON SEVERAL TIMES; THEN, A HOLE WAS CREATED IN THE BENT POINT [CATHETER BREAKAGE]. WATER INSIDE THE BALLOON STARTED LEAKING FROM THE HOLE, SO THE DEVICE WAS REPLACED WITH ANOTHER BALLOON, AND THE PROCEDURE WAS COMPLETED WITH THE REPLACEMENT DEVICE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. 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 7748285 ↗