Hercules G51798Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 00827002517981), received between Apr 26, 2016 and Aug 31, 2026 — classified as 4 injuries, 52 malfunctions.

The most frequently reported specific device problem is “Crack” (22 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjuryAug 31, 2026Adverse Event Without Identified Device or Use Problem

  During an esophageal dilation procedure, the physician used a Cook HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. It was reported that the physician experienced an inability to feel resistance and was unable to visualize the distal end of the balloon during inflation. The dilation tear in the patient's tissue was larger than expected. It is unknown how the procedure was completed. A picture was provided showing an endoscopic view of reported "dilation tear in the patient's tissue." An additional picture shows the device in vivo and the balloon is inflated within the stricture. A section of the device did not remain inside the patient¿s body. The patient experienced a larger tear to tissue than expected. According to the initial reporter, it is unknown how the procedure was completed.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 50525348 ↗
• MalfunctionAug 25, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50438231 ↗
• MalfunctionAug 25, 2026Difficult to Remove

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50437868 ↗
• MalfunctionDec 17, 2025Fracture; Fracture

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED THAT WATER [WAS] LEAKING OUT OF THE BOTTOM OF BALLOON WHEN ATTEMPTING TO INFLATE WITH WATER. UNABLE TO INFLATE BALLOON FOR DESIRED PURPOSE. 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 23829393 ↗
• MalfunctionSep 8, 2025Fracture; Fracture

  DURING AN ESOPHAGEAL DILATION, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE CATHETER RUPTURED, LEADING TO BALLOON DEFLATION. 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 22998259 ↗
• MalfunctionSep 8, 2025Fracture; Fracture

  IN PREPARATION FOR A GASTROVASCULAR DILATION PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE CATHETER WAS KINKED WHEN CHECKING IT PRIOR TO INSERTION. ANOTHER DEVICE OF THE SAME RPN WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ON 13AUG2025, THE CUSTOMER PROVIDED PICTURES SHOWING CATHETER APPEARING TO BE KINKED AND BROKEN [SUBJECT OF REPORT]. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22995136 ↗
• InjuryApr 21, 2025Use of Incorrect Control/Treatment Settings; Device Damaged by Another Device; Use of Incorrect Control/Treatment Settings; Device Damaged by Another Device

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] THE DILATION BALLOON WAS INFLATED WITH ANOTHER MANUFACTURER'S INFLATION SYRINGE WITH INTEGRAL MANOMETER. DURING INFLATION, THE MANOMETER NEEDLE DID NOT MOVE. THE IDE; THEREFORE, HAD NO INFORMATION ON THE PRESSURE OF THE DILATATION BALLOON. PROBABLY OVER-INFLATION. DIFFICULTY ALSO DETECTED WHEN REMOVING THE BALLOON (NO COMPLETE DEFLATION). PATIENT SUFFERED A DEEP AND HEMORRHAGIC LACERATION OF THE ESOPHAGUS HAS BEEN GENERATED BY EXCESSIVE PRESSURE (PRESSURE COULD NOT BE CONTROLLED). THIS REQUIRED PLACEMENT OF THREE HEMOSTATIC CLIPS TO CLOSE THE LACERATION.

  Patient problems: Laceration(s) of Esophagus

  MAUDE report 21875262 ↗
• MalfunctionMar 21, 2025Fracture; Fracture

  DURING A BALLOON DILATION IN DISTAL ESOPHAGUS, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. IT WAS REPORTED [THAT] AFTER INFLATING BALLOON TO 20MM (6ATM), USER WANTED TO DEFLATE THE BALLOON BUT IT WASN¿T POSSIBLE; WATER STAYED IN THE BALLOON. THE NURSE REALIZED THAT DROPS OF WATER CAME OUT OF THE VALVE AT UPPER END OF WORKING CHANNEL. THEN THEY TOOK OUT CAREFULLY THE SCOPE TOGETHER WITH THE BALLOON; THEY REALIZED THAT THE BLUE CATHETER SHEATH WAS RUPTURED IN UPPER PART. THE CATHETER WAS THE CUT TO BE ABLE TO TAKE IT OUT OF THE ENDOSCOPE CHANNEL. NEW BALLOON WAS USED AND DILATION WAS REPEATED AND PROCEDURE FINISHED 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 21665771 ↗
• MalfunctionDec 12, 2019Crack; Crack

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. DURING INSERTION OF THE DEVICE INTO THE WORKING CHANNEL THE CATHETER GOT KINKED AND THE BALLOON COULD NOT BE USED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS EVENT WAS NOT REPORTABLE AT THE TIME. THE DEVICE WAS RECEIVED ON 15-NOV-2019 AND THERE WAS A SECTION ON THE DISTAL END OF THE BLUE CATHETER THAT WAS CRACKED. 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 9460461 ↗
• MalfunctionNov 21, 2019Crack; Crack

  PRIOR TO A PROCEDURE, THE NURSE OPENED THE PACKAGING OF A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC FINDING IT TO BE ALREADY BROKEN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 10/18/2019 FROM THE CUSTOMER NOTING THE CATHETER WAS TORN APART OR BROKEN FROM THE WHITE HOLDER [USER END]. THEY SAW IT IMMEDIATELY WHEN THEY OPENED THE PACKAGE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. ADDITIONAL INFORMATION RECEIVED ON 10/29/2019 WHEN THE DEVICE WAS RETURNED, NOTING THE CATHETER WAS BROKEN AT THE USER END. THIS OBSERVATION WAS MADE PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9356009 ↗
• MalfunctionNov 12, 2019Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON LEAKED WHILE BEING INFLATED INSIDE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NEW 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 9311886 ↗
• MalfunctionJun 13, 2019Crack; Crack

  IN PREPARATION FOR A PROCEDURE, THE USER SELECTED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC (HBD-W-18-19-20). THE CATHETER WAS KINKED WHEN THE PRODUCT WAS TAKEN OUT OF THE PACKAGE. [THEY] USED ANOTHER HBD-W WITHOUT ANY PROBLEM. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 29-MAY-2019: A CRACK IN THE CATHETER WAS OBSERVED APPROXIMATELY 118.2 CM FROM THE DISTAL END (SUBJECT OF THIS REPORT). THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 8695530 ↗
• MalfunctionMay 31, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGEAL DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICE HAD A LEAK IN THE BALLOON. THE CUSTOMER STARTED DILATION AND THE FIRST STAGE WAS FINE. DURING THE SECOND STAGE, A LEAK WAS OBSERVED. IT WAS PROBABLY CHARACTERIZED AS A PINHOLE LEAK. THEY REMOVED IT AND USED UNKNOWN MANUFACTURER PRODUCT 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 8659252 ↗
• MalfunctionMay 31, 2019Burst Container or Vessel; Burst Container or Vessel

  DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. AT THE BEGINNING OF THE ERCP PROCEDURE, IT WAS NOTED THAT DILATION OF THE DUODENAL CHANNEL WITH A HYDROSTATIC BALLOON WAS NECESSARY. HOWEVER, WHEN THE PRESSURE REACHED 5 ATM, THE BALLOON BURST. THE BALLOON WAS LUBRICATED BEFORE BEING INTRODUCED INTO THE WORKING CHANNEL AND NEGATIVE PRESSURE WAS APPLIED. AFTER POSITIONING, THE BALLOON WAS FILLED WITH WATER AND APPLIED PRESSURE THROUGH THE INSUFFLATION SYRINGE. IT WAS NECESSARY TO USE ANOTHER BALLOON DILATOR. IN A PHOTO PROVIDED BY THE CUSTOMER, IT APPEARS THAT THE TIP OF THE DEVICE AND A PORTION OF THE BALLOON IS MISSING. ADDITIONAL INFORMATION WAS RECEIVED ON 23-MAY-2019: THE TIP OF THE BALLOON CAME LOOSE INSIDE THE WORKING CHANNEL WHEN THE DEVICE HAD BEEN TAKEN FROM THE DUODENOSCOPE, OUTSIDE THE PATIENT. IT WAS REMOVED WITH A CLEANING BRUSH AND DISCARDED AT THE TIME OF CLEANING THE EQUIPMENT, SO IT DOES NOT APPEAR IN THE PHOTO. 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8659250 ↗
• MalfunctionMay 1, 2019Crack; Crack

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICE WOULD NOT FEED THROUGH THE ENDOSCOPE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 08-APR-2019. THE BLUE 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 8569677 ↗
• MalfunctionMay 1, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED THREE (3) HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICES POPPED, THUS LEAKED. 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 8568862 ↗
• MalfunctionApr 26, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC. THE FIRST DEVICE WAS PUT DOWN THE ENDOSCOPE. THEY TRIED TO INFLATE IT AND THE BALLOON BEGAN TO LEAK (SUBJECT OF THIS REPORT). A SECOND DEVICE WAS PUT DOWN THE ENDOSCOPE. THEY TRIED TO INFLATE IT AND THIS BALLOON ALSO BEGAN TO LEAK (SEE RELATED MDR 1037905-2019-00218). 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 8554706 ↗
• MalfunctionApr 26, 2019Material Puncture/Hole; Material Puncture/Hole

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED TWO (2) HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC. THE FIRST DEVICE WAS PUT DOWN THE ENDOSCOPE THEY TRIED TO INFLATE IT AND THE BALLOON BEGAN TO LEAK (SEE RELATED MDR 1037905-2019-00217). A SECOND DEVICE WAS PUT DOWN THE ENDOSCOPE. THEY TRIED TO INFLATE IT AND THIS BALLOON ALSO BEGAN TO LEAK (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 8554705 ↗
• MalfunctionApr 19, 2019Material Puncture/Hole; Use of Device Problem; Material Puncture/Hole; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD), THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. WHILE PERFORMING AN ESOPHAGEAL DILATION, WHEN THE BALLOON WAS INTRODUCED INTO THE WORKING CHANNEL OF THE ENDOSCOPE, THE DOCTOR SAW THE DEFECT. THE CATHETER ON THE DISTAL END CAME LOOSE AND WHEN INSUFFLATING, THE CONTRAST MEDIUM GOES OUT [LEAKS] AND THE PROCEDURE COULD NOT CONTINUE. THERE WAS NO ADDITIONAL COMPLICATION WITH THE PATIENT. THE PHYSICIAN CHANGED THE BALLOON FOR ANOTHER MANUFACTURER'S DEVICE AND THE PROCEDURE CONTINUED. 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 8531478 ↗
• MalfunctionOct 26, 2018Crack; Crack

  DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIRE GUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. AFTER PLACING THE WIRE GUIDED BALLOON THROUGH THE GASTROSCOPE, THE OUTER SHEATH BROKE, EXPOSING FRAYED GUIDE WIRE. THE DEVICE WAS RECEIVED FOR EVALUATION ON 15-OCT-2018 AND WAS FOUND TO HAVE A PORTION OF THE BALLOON MATERIAL WAS CUT FROM THE DISTAL END. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 16-OCT-2018: THE BALLOON WAS CUT AFTER REMOVING [FROM] THE PATIENT TO FACILITATE REMOVING [IT] FROM THE ENDOSCOPE. 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 8009400 ↗
• MalfunctionOct 5, 2018Crack; Crack

  DURING A DILATION PROCEDURE THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE CATHETER OF THE BALLOON WAS BROKEN; INFLATION WAS NOT POSSIBLE. 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 7937942 ↗
• MalfunctionAug 31, 2018Leak/Splash; Leak/Splash

  DURING A DILATION PROCEDURE, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOON ESOPHAGEAL-PYLORIC-COLONIC. THE BALLOON DEFLATED; THERE WAS A HOLE IN THE WIRE [CATHETER]. THE FOLLOWING REPORT WAS RECEIVED ON (B)(6) 2018: "EXAMINATION IN THE LABORATORY CONFIRMED THE DEFECT REPORT. THE SMTL (SURGICAL MATERIALS TESTING LABORATORY) RECEIVED ON (B)(6) 2018, ONE COOK IRELAND HERCULES 3 STAGE WIRE GUIDED BALLOON, SIZE 18-19-20 MM, PRODUCT NUMBER G51798, BATCH NUMBER W3932889. THE ACCOMPANYING DEFECT REPORTING FORM SENT IN BY [THE USER FACILITY] STATES: 'USING DILATION BALLOON. THE BALLOON WAS NOT STAYING INFLATED. WHEN [IT WAS] TESTED AFTER, [THERE WAS A] HOLE IN WIRE [CATHETER] - NOT BALLOON. NO HARM TO PATIENT.' IN THE LABORATORY, THE PUTATIVE DEFECTIVE DEVICE WAS CONNECTED TO A SYRINGE FILLED WITH WATER. A LEAK WAS IDENTIFIED FROM A SMALL KINK AND HOLE IN THE WIRE [CATHETER]. IT WAS ALSO NOTICED THAT A SMALL AMOUNT OF WATER LEAKED FROM THE CONNECTING PORT. AN IMAGE WAS TAKEN AND IS INCLUDED WITH THE REPORT." OUR ATTEMPTS TO COLLECT ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WERE UNSUCCESSFUL. HOWEVER, INFORMATION IN THE SMTL REPORT INDICATES THAT THERE WAS "NO HARM TO

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7839149 ↗
• MalfunctionJul 13, 2018Crack; Product Quality Problem; Use of Device Problem; Crack; Product Quality Problem; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICE WOULD NOT FIT DOWN THE ENDOSCOPE CHANNEL. THEY SWITCHED FROM AN OLYMPUS Q190 ENDOSCOPE TO AN OLYMPUS Q180 ENDOSCOPE AND STILL HAD THE SAME PROBLEM (2.8 MM CHANNEL SIZE FOR BOTH ENDOSCOPES). THIS PROBLEM OCCURRED WITH THREE (3) DIFFERENT DEVICES [EACH FROM DIFFERENT LOTS] IN THE SAME CASE. THEY WENT TO A SMALLER SIZED BALLOON, AND IT WAS SUCCESSFUL. THEY SUCCESSFULLY FINISHED THE CASE BY DILATING UP TO 18 MM. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED AND EVALUATED ON 19-JUN-2018 AND WAS FOUND TO HAVE A CRACK 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 7687387 ↗
• MalfunctionJul 13, 2018Crack; Use of Device Problem; Crack; Use of Device Problem

  DURING AN ESOPHAGOGASTRODUODENOSCOPY, THE PHYSICIAN USED A COOK HERCULES 3 STAGE WIREGUIDED BALLOONS ESOPHAGEAL-PYLORIC-COLONIC. THE DEVICE WOULD NOT FIT DOWN THE ENDOSCOPE CHANNEL. THEY SWITCHED FROM AN OLYMPUS Q190 ENDOSCOPE TO AN OLYMPUS Q180 ENDOSCOPE AND STILL HAD THE SAME PROBLEM (2.8 MM CHANNEL SIZE FOR BOTH ENDOSCOPES). THIS PROBLEM OCCURRED WITH THREE (3) DIFFERENT DEVICES [EACH FROM DIFFERENT LOTS] IN THE SAME CASE. THEY WENT TO A SMALLER SIZED BALLOON, AND IT WAS SUCCESSFUL. THEY SUCCESSFULLY FINISHED THE CASE BY DILATING UP TO 18 MM. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED AND EVALUATED ON 19-JUN-2018 AND WAS FOUND TO HAVE A CRACK 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 7687382 ↗
• MalfunctionJun 11, 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 TO DILATE THE PYLORIC STENOSIS. WHEN ADVANCING THE DEVICE THROUGH AN ENDOSCOPE WITH A F2.8 MM ACCESSORY CHANNEL, THE PHYSICIAN FELT STRONG RESISTANCE, AS IF IT WAS CAUGHT ON SOMETHING. HE WAS ABLE TO ADVANCE IT TO THE TARGET SITE DESPITE THE RESISTANCE, SO DILATION WAS PERFORMED WITH AN INFLATED 18 MM DIAMETER BALLOON. AFTER THAT, HE ATTEMPTED TO RETRACT THE BALLOON INTO THE ENDOSCOPE IN ORDER TO ADJUST A DILATING POSITION, BUT RESISTANCE DISTURBED THE ATTEMPT. THEREFORE, THE ENDOSCOPE WITH THE DEVICE STILL INSERTED WAS REMOVED FROM THE PATIENT, THEN THE DEVICE WAS REMOVED FROM THE ENDOSCOPE OUTSIDE THE PATIENT BY REWRAPPING [WRAPPED/FOLDED THE BALLOON MATERIAL BY HAND] THE BALLOON MANUALLY. THE ENDOSCOPE WAS RE-ADVANCED TO THE TARGET SITE AND THE USER ATTEMPTED TO INSERT THE DEVICE INTO THE ACCESSORY CHANNEL AGAIN FOR ANOTHER TRY, BUT IT COULD NOT BE INSERTED. SINCE THERE WAS NO BACK-UP DEVICE, THE PROCEDURE WAS ABANDONED AT THAT POINT ALTHOUGH THE STENOSIS HAD NOT BEEN DILATED UP TO THE PLANNED DIAMETER. THERE HAVE BEEN NO ADVERSE EFFECTS TO T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589037 ↗