AutoCap™ RX M00545100Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729994701), received between Feb 19, 2024 and Sep 21, 2026 — classified as 6 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fluid/Blood Leak

  It was reported to Boston Scientific Corporation that an AutoCap was used during an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure performed on (b)(6) 2026.The AutoCap leaked during the procedure. The procedure was completed using another of the same device.There were no patient complications reported as a result of this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50840871 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  HOLD FOR DU/7/15.IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP WAS USED FOR DUODENUM DURING AN ERCP PROCEDURE ON (B)(6)2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, AIR AND WATER WERE OBSERVED LEAKING FROM THE BIOPSY BUNG CAP. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25820417 ↗
• MalfunctionJul 14, 2026Fluid/Blood Leak

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP WAS USED FOR DUODENUM DURING AN ERCP PROCEDURE ON (B)(6) 2026, FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, AIR AND WATER WERE OBSERVED LEAKING FROM THE BIOPSY BUNG CAP. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25814039 ↗
• MalfunctionJun 2, 2026Detachment of Device or Device Component; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, WHILE THE PHYSICIAN WAS WITHDRAWING A BALLOON, THE FOAM FROM THE AUTOCAP DETACHED. SUBSEQUENTLY, NO ADDITIONAL DEVICES COULD BE ADVANCED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25365594 ↗
• MalfunctionMay 13, 2026Material Separation

  It was reported to Boston Scientific Corporation that AutoCap RX was used during an Endoscopic Retrograde Cholangeopancreatography (ERCP) procedure on (B)(6) 2026. During scope reprocessing, a small rubber filter of the AutoCap RX was found inside the scope. The procedure was completed was completed. There were no patient complications reported as a result after this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162770 ↗
• MalfunctionFeb 2, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STONES ON (B)(6) 2026. DURING THE PROCEDURE, THE FOAM PIECE FROM THE AUTOCAP RX DETACHED FROM THE CAP. THE PROCEDURE WAS COMPLETED WITH A SECOND AUTOCAP RX. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL INFORMATION WAS RECEIVED ON FEBRUARY 3, 2026: IT WAS REPORTED THAT THE ANATOMY LOCATION OF THE PROCEDURE IS COMMON BILE DUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240544 ↗
• MalfunctionDec 15, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, A LAYER OF SILICONE FRAGMENT OF THE AUTOCAP RX LOCKING DEVICE BROKE OFF AND FELL INTO THE SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803075 ↗
• InjuryNov 20, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP WAS USED IN AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE TREATMENT OF STRICTURE ON (B)(6) 2025. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC PLASTIC STENT WAS BEING PLACED. DURING PLACEMENT, THE PLASTIC COMPONENT OF THE AUTOCAP DETACHED AND BECAME LODGED ON THE SECOND STENT THAT WAS INSERTED. A RESCUE GRASPING FORCEPS DEVICE WAS USED TO RETRIEVE THE DISLODGED PART. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23605530 ↗
• MalfunctionSep 2, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE STENT WAS ADVANCED THROUGH THE AUTOCAP, THE SPONGE AND THE RINGS FELL OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22936659 ↗
• MalfunctionAug 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AUTOCAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE BILE DUCT STONES REMOVAL ON (B)(6) 2025. DURING A PROCEDURE INVOLVING THE USE OF A GUIDEWIRE, RESISTANCE WAS ENCOUNTERED WHILE ATTEMPTING TO SLIDE THE GUIDEWIRE THROUGH THE DEVICE'S OPENING. EXCESSIVE FORCE WAS REQUIRED, AND SUBSEQUENTLY, A PIECE OF THE DEVICE'S SPONGE COMPONENT DETACHED AND ENTERED THE WORKING CHANNEL. THE SPONGE PIECE WAS SUCCESSFULLY RETRIEVED WHEN SCOPE REMOVED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22727197 ↗
• MalfunctionJul 29, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AUTOCAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE FOR THE STONE REMOVAL ON (B)(6) 2025. DURING THE PROCEDURE, THE CAP APPEARED DAMAGED, AND THE SPONGE DISLODGED. DUE TO THE ADDITION OF MATERIALS, THE CAP COULD NOT BE REPLACED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22650291 ↗
• InjuryJul 15, 2025Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2025, FOR THE TREATMENT OF THE STRICTURE. DURING STENT PLACEMENT, IT WAS NOTED THAT A PLASTIC DISC HAD DISLODGED FROM THE AUTOCAP DEVICE. THE PHYSICIAN WAS ABLE TO CUT THE DISLODGED COMPONENT USING ENCISSERS AND RETRIEVED IT USING RAT TOOTH FORCEPS. THE PROCEDURE WAS THEN COMPLETED SUCCESSFULLY USING THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507284 ↗
• MalfunctionMay 1, 2025Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN AUTOCAP RX WAS USED FOR THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025. WHEN THEY ATTEMPTED TO PUT THE LOCKING DEVICE ON THE ERCP SCOPE, IT WAS OBSERVED THAT THE PACKAGING WAS OPENED AND STERILITY WAS COMPROMISED. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21942183 ↗
• MalfunctionApr 30, 2025Leak/Splash; Difficult to Advance; Leak/Splash; Difficult to Advance

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED FOR THE TREATMENT OF CHOLEDOCHOLITHIASIS ON (B)(6) 2025. DURING THE PROCEDURE, THE AUTOCAP RX CONTINUOUSLY LEAKED, MAKING INSTRUMENTS DIFFICULT TO ADVANCE. THE PHYSICIAN REPORTED THAT A SIGNIFICANT AMOUNT OF BILE DRIPPED ONTO HIS GLOVES AND THE FLOOR. THEY INJECTED LUBE TO RESOLVE THE ISSUE, BUT IT WAS A VERY BRIEF FIX. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21934741 ↗
• MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE AUTOCAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOPOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF STONES ON (B)(6) 2025. DURING THE PROCEDURE, WHEN THE PHYSICIAN PULLED THE STENT THROUGH THE AUTOCAP, THE WHITE PART INSIDE THE CAP OF THE BLUE HOUSING WAS PULLED AS WELL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21631682 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024. DURING THE PROCEDURE, THE SPONGE DETACHED FROM THE CAP. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21106398 ↗
• MalfunctionOct 31, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, WHEN THE DOCTOR SUCCESSFULLY REMOVED A PLASTIC STENT USING A RAT TOOTH FORCEPS THROUGH THE SCOPE AND THE AUTOCAP DEVICE CONNECTED TO THE BIOPSY PORT. WHILE TRYING TO INSERT A TOME DOWN THE AUTOCAP, THE DOCTOR ENCOUNTERED RESISTANCE, INDICATING SOMETHING WAS LODGED IN THE SCOPE. THE DOCTOR ATTEMPTED TO DISLODGE THE OBSTRUCTION BY JIGGLING THE TOME SEVERAL TIMES. AFTER UNSUCCESSFUL ATTEMPTS TO CLEAR THE BLOCKAGE, THE DOCTOR REMOVED THE AUTOCAP. UPON PULLING OUT THE TOME, A PIECE OF THE AUTOCAP WAS FOUND STUCK TO IT. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20581665 ↗
• InjuryOct 14, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A BRISTLE DISC FROM THE AUTOCAP RX WAS LOOSENED AND PUSHED THROUGH THE SCOPE INTO THE PATIENT. AFTER STENT PLACEMENT, THE BRISTLE DISC WAS RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440377 ↗
• InjurySep 3, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE. AT THE END OF THE PROCEDURE, DURING A PLASTIC STENT INSERTION, A BRISTLE DISC FROM THE AUTOCAP RX FELL OUT OF THE SCOPE AND INTO THE PATIENT'S DUODENUM. THE PHYSICIAN REPORTED THAT THE BRISTLE DISC WAS RETRIEVED. THE PROCEDURE WAS COMPLETED BY PLACING A STENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127018 ↗
• InjurySep 3, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON AN UNKNOWN DATE, FOR THE TREATMENT OF STONES OR STRICTURE. DURING THE PROCEDURE, WHEN THE SPYSCOPE WAS ADVANCED DOWN THE AUTOCAP RX, THE PHYSICIAN NOTICED THAT A BROKEN PIECE OF AUTOCAP WAS ATTACHED TO THE END OF THE SPYSCOPE INSIDE THE BILE DUCT. REPORTEDLY, THE SPYSCOPE WAS REMOVED, AND THE BROKEN FRAGMENT WAS RETRIEVED. THEN THE SPYSCOPE WAS REINSERTED. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20124962 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024, FOR THE TREATMENT OF BILIARY OBSTRUCTION. DURING THE PROCEDURE, THE YELLOW SPONGE CAME OUT ON TOP OF THE AUTOCAP LOCKING DEVICE. THE SPONGE WAS NOT PUSHED INSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19938003 ↗
• MalfunctionAug 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024, FOR THE TREATMENT OF BILIARY OBSTRUCTION. DURING THE PROCEDURE, THE YELLOW SPONGE CAME OUT ON TOP OF THE AUTOCAP LOCKING DEVICE. THE SPONGE WAS NOT PUSHED INSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937996 ↗
• MalfunctionJul 25, 2024Material Separation; Material Separation

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024 FOR THE TREATMENT OF COMMON BILE DUCT STONES. AT THE END OF THE PROCEDURE, DURING A PLASTIC STENT INSERTION, A BRISTLE DISC FROM THE AUTOCAP RX WAS FOUND IN THE AMPULLA. THE PHYSICIAN REPORTED THE DISC WILL BE REMOVED UPON REMOVAL OF THE PLASTIC STENT. THE PROCEDURE WAS COMPLETED USING THE ORIGINAL AUTOCAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19825760 ↗
• MalfunctionJul 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED IN PANCREAS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2024, FOR THE TREATMENT OF PANCREATIC DUCT STONES. DURING THE PROCEDURE, A JAGTOME REVOLUTION WAS FIRST ADVANCED THROUGH THE AUTOCAP INTO THE PANCREATIC DUCT THROUGH A PLASTIC STENT. THE WIRE WAS LEFT BEHIND AND JAGTOME WAS REMOVED OUT OF THE SCOPE. A CAPTIVATOR LL ROUND SNARE WAS ADVANCED OVER THE WIRE AND PASSED THROUGH THE AUTOCAP, DOWN THE WORKING CHANNEL AND OUT INTO THE DUODENUM. WHEN OPENING THE SNARE TO REMOVE THE PLASTIC STENT FROM THE PANCREATIC DUCT, THE SPONGE WAS NOTED AROUND THE WIRE OF THE SNARE. REPORTEDLY, IT WAS IDENTIFIED THAT THE SPONGE ATTACHED TO THE SNARE WIRE CAME FROM THE AUTOCAP UPON DISASSEMBLING. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE AND ANOTHER SCOPE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19669414 ↗
• MalfunctionJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AUTOCAP RX WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THEY PLACED A DEVICE THROUGH AUTOCAP THE RYNEL PU FOAM INSIDE THE CAP WAS DISLODGED. IT IS UNKNOWN IF THE FOAM WAS PUSHED INTO THE SCOPE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19467224 ↗