Hercules G51797Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00827002517974), received between Jul 8, 2016 and Sep 16, 2026 — classified as 1 injury, 57 malfunctions.

The most frequently reported specific device problem is “Crack” (23 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791822 ↗
• MalfunctionAug 21, 2026Fracture; Improper or Incorrect Procedure or Method

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50376273 ↗
• MalfunctionAug 11, 2026Fluid/Blood Leak

  During a gastrointestinal dilation procedure, the physician used a Cook HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. It was reported that there was a small hole in the balloon as it would not inflate to (b)(6) "[atm]".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 50215437 ↗
• MalfunctionAug 11, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213208 ↗
• MalfunctionJul 1, 2026Fracture

  DURING A PYLORIC DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE USER PUT THE BALLOON INTO THE SCOPE AND IT WAS SO DIFFICULT TO REMOVE FROM THE ENDOSCOPE THAT THEY DAMAGED THE BALLOON WHILE PULLING IT OUT. THEY HAD TO REMOVE THE ENDOSCOPE FROM THE PATIENT AND THEN RE-ENTERED THE ENDOSCOPE 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 25683505 ↗
• MalfunctionJul 1, 2026Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE CATHETER BROKE IN THE MIDDLE. 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 25680105 ↗
• MalfunctionApr 16, 2026Fracture

  IN PREPARATION FOR AN ESOPHAGEAL DILATION, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS INITIALLY REPORTED THAT THE PROTECTIVE OUTER PLASTIC SHEATH WAS OBSERVED TO BE CRACKED AND DAMAGED. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME AS THIS WAS INTERPRETED AS DAMAGE TO THE BALLOON PROTECTOR [DEFECTIVE PRIOR TO USE]. THE DEVICE WAS RETURNED ON 23MAR2026, AND IT WAS DETERMINED THAT THE DEVICE APPEARS TO HAVE BEEN USED WITH A STICKY CLEAR SUBSTANCE ON THE ENTIRE DEVICE. THE BLUE OUTER CATHETER WAS BROKEN IN TWO SECTIONS AT 15.1 CM AND 19.9 CM FROM THE DISTAL TIP OF 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 24897484 ↗
• MalfunctionMar 30, 2026Fracture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE CATHETER SNAPPED WHILE DOWN THE [ENDOSCOPE] CHANNEL. NO PATIENT CONTACT WAS MADE AND THEY [USER] WERE ABLE TO PULL OUT THE PRODUCT OF THE SCOPE AND JUST USED A NEW ONE 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 24734863 ↗
• MalfunctionMar 17, 2026Fracture

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT THE [USER] OPENED THE PACKAGE AND NOTICED THAT THE PRODUCT WAS DEFECTIVE. BALLOON WAS LEAKING. A NEW COOK HBD-W BALLOON DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE DEVICE WAS EVALUATED AND IT WAS DETERMINED THAT THE CATHETER HAD A BREAK [SUBJECT OF REPORT]. THIS OCCURRED DURING A PRODUCT DEMONSTRATION; NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618214 ↗
• MalfunctionFeb 19, 2026Fluid/Blood Leak

  DURING AN UPPER GI ENDOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] UPON ATTEMPTING TO INFLATE THE DILATION BALLOON, IT WAS NOT FILLING WITH WATER PROPERLY [INTERPRETED TO BE BALLOON 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 24387811 ↗
• MalfunctionOct 28, 2025Material Rupture; Improper or Incorrect Procedure or Method; Material Rupture; Improper or Incorrect Procedure or Method

  DURING AN ENDOSCOPIC DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT DURING THE BEGINNING OF BALLOON INFLATION, THE LIQUID BEGAN TO LEAK THROUGH THE CATHETER, MAKING IT NECESSARY TO OPEN ANOTHER BALLOON 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 23407765 ↗
• MalfunctionAug 21, 2025Fracture; Fracture

  DURING AN ESOPHAGEAL BALLOON DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] WHILE PUSHING THE CATHETER INTO THE SCOPE, IT UNFORTUNATELY GOT DAMAGED [CATHETER BREAKAGE]. 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 22859800 ↗
• MalfunctionJul 14, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT IN THE INFLATION PROCESS, THERE WAS A RUPTURE OF THE OUTER TUBE, AND THE MATERIAL WAS REMOVED WITHOUT THE NEED FOR EMPTYING DUE TO THE RUPTURE. 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 22494634 ↗
• MalfunctionJul 7, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  DURING AN ESOPHAGEAL BALLOON DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] DURING PASSAGE OF THE BALLOON THROUGH THE WORKING CHANNEL OF THE ENDOSCOPE, THE CATHETER WITH THE GUIDE FRACTURED AND DID NOT ALLOW THE BALLOON TO BE 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 22420357 ↗
• InjuryApr 25, 2025Material Rupture; Material Rupture

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT DURING THE PRESSURE INCREASE FROM 16.5 MM TO 18 MM LEVEL, THE BALLOON BURSTS ABRUPTLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT REQUIRED APPLICATION OF ENDOSCOPIC CLIPS TO CLOSE THE LACERATION CAUSED BY THE BALLOON RUPTURE.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 21909843 ↗
• MalfunctionMar 28, 2025Fracture; Fracture

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY [ERCP] IN THE SMALL BOWEL, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] WHEN ATTEMPTING INFLATE THE BALLOON TO 5MM, THE BALLOON STARTED LOSING PRESSURE. WHEN THE BALLOON WAS REMOVED, IT WAS NOTED TO HAVE A HOLE. THERE WAS NOT REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 05MAR2025 AND IT WAS DETERMINED THAT THERE WERE TWO BREAKS IN THE BLUE CATHETER EXPOSING THE PURPLE TUBING [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 21721041 ↗
• MalfunctionSep 2, 2020Fracture; Fracture

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON WAS NOT HOLDING PRESSURE. THE DISTAL END OF THE BALLOON WAS NOTED TO HAVE A HOLE AND WAS LEAKING WATER. THE PROCEDURE WAS COMPLETED WITH 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 Consequences Or Impact To Patient

  MAUDE report 10482296 ↗
• MalfunctionMar 4, 2020Fracture; Fracture

  DURING AN ESOPHAGECTOMY UPPER DIGESTIVE ENDOSCOPYPROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE CATHETER 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 9788012 ↗
• MalfunctionFeb 24, 2020Material Rupture; Material Rupture

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) PROCEDURE, THE PHYSICIAN USED A HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON LEAKED DURING THE PROCEDURE. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9746913 ↗
• MalfunctionJan 16, 2020Break; Crack; Fracture; Break; Crack; Fracture

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON. THE GUIDE [CATHETER] BENT AND BROKE DURING INSERTION 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. ADDITIONAL INFORMATION WAS PROVIDED ON 12-FEB 2020 THAT INDICATED THE BALLOON WAS TESTED PRIOR TO USE AND A 20ML (CC) SYRINGE WITH AN ATM/PSI WITH A METER WAS USED TO INFLATE THE BALLOON [AGAINST THE INSTRUCTIONS FOR USE]. 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 9597551 ↗
• MalfunctionDec 31, 2019Crack; Crack

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON COULD NOT LEAVE THE OPERATOR CHANNEL. AS SOON AS THE CATHETER WAS INTRODUCED INTO THE WORKING CHANNEL, A STRONG FEELING OF FRICTION EXISTED. THE CATHETERS WERE CHANGED WITHOUT CONSEQUENCES TO THE PATIENT. THIS EVENT WAS NOT REPORTABLE AT THE TIME. THE DEVICE WAS RECEIVED ON (B)(6) 2019 AND IT WAS NOTED THE BLUE CATHETER WAS BROKEN. OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. WHILE THE COMPLAINANT DID NOT SPECIFY IF THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS OR REQUIRED ADDITIONAL MEDICAL PROCEDURES DUE TO THIS EVENT, THE INFORMATION ABLE TO BE COLLECTED DOES NOT REASONABLY SUGGEST THE PATIENT WAS ADVERSELY IMPACTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9536206 ↗
• MalfunctionSep 27, 2019Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  DURING AN ANAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHILE DOING THE DILATION, THE BALLOON MOUNT OVER THE SHEATH GOT DISCONNECTED [BALLOON DETACHES FROM CATHETER]. IT COULD BE TAKEN OUT WITH THE HELP OF FOREIGN BODY FORCEPS. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE BALLOON WAS ELECTIVELY RETRIEVED WITH FORCEPS 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; No Consequences Or Impact To Patient

  MAUDE report 9131951 ↗
• MalfunctionSep 23, 2019Crack; Crack

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE WIRE WOULD NOT ADVANCE THROUGH CATHETER AND BECAME BENT DURING ATTEMPT. THE BALLOON AND WIRE WERE REMOVED AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 29-AUG-2019. THERE WAS A CRACK IN THE BLUE 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 9106118 ↗
• MalfunctionJul 8, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE PATIENT SUBMITTED TO A DILATION OF AN ANASTOMOSIS, BUT THE BALLOON HAD A FISSURE [LEAK], SPILLING OUT WATER. WITHOUT SUCCESS IN THE BALLOON INSUFFLATION, IT WAS NECESSARY TO USE ANOTHER PRODUCT [TO COMPLETE THE DILATION 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 8767836 ↗
• MalfunctionApr 19, 2019Crack; Crack

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THEY WENT DOWN THE ENDOSCOPE [WITH THE DEVICE], FILLED THE INFLATION [DILATION] BALLOON WITH WATER, AND THE BALLOON WOULD NOT INFLATE AT ALL. A NEW SAME DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 03/27/2019. THE CATHETER LEAKED FROM A CRACK AT THE DISTAL END NEAR THE BALLOON. OUR EVALUATION OF THE RETURNED DEVICE DETERMINED A PORTION OF THE BLUE CATHETER IS MISSING AND WAS NOT INCLUDED IN THE RETURN OF THE DEVICE. THIS INFORMATION WAS COMMUNICATED TO THE USER FACILITY AND THE LOCATION OF THE MISSING SECTION IS UNKNOWN. THE INITIAL REPORTER STATED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY; HOWEVER THE LOCATION OF THE MISSING SECTION DETECTED DURING OUR LABORATORY EVALUATION IS UNKNOWN. 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 8531476 ↗