RX Locking Device and Biopsy Cap M00545260Recalls & reported problems

Summary

The FDA's MAUDE database contains 216 adverse event reports that list this exact device (DI 08714729746676), received between Nov 23, 2016 and Sep 29, 2026 — classified as 3 injuries, 213 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (167 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 216 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931053 ↗
• MalfunctionAug 6, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165740 ↗
• MalfunctionApr 3, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE WITHIN THE BIOPSY CAP DETACHED AND WAS LODGED IN THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779036 ↗
• MalfunctionApr 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE WITHIN THE BIOPSY CAP DETACHED AND WAS LODGED IN THE SCOPE. IT WAS REMOVED IN THE CLEANING ROOM. THE PROCEDURE WAS COMPLETED WITH A NEW SCOPE AND RX LOCKING DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24756343 ↗
• MalfunctionFeb 18, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED FOR COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE SPONGE FROM THE BIOPSY CAP AND LOCKING DEVICE ENTERED THE SCOPE CHANNEL. THE DETACHED PIECE WAS EXTRACTED DURING MANUAL CLEANING. THE PROCEDURE WAS COMPLETED USING A NEW ENDOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24384688 ↗
• MalfunctionJan 27, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE BIOPSY CAP SPONGE BECAME DISLODGED AND FELL INTO THE SCOPE CHANNEL. THE CAP WAS MANIPULATED USING THE DISTAL TIP WIRE HOLDER, AND LUBRICANT WAS APPLIED TO THE BALLOON CATHETER TO ASSIST IN THE PROCESS. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24193450 ↗
• MalfunctionJan 7, 2026Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON UN UNKNOWN DATE FOR THE TREATMENT OF STRICTURE. DURING THE PROCEDURE, THE SPONGE FROM THE LOCKING DEVICE BECAME LODGED IN THE SCOPE CHANNEL DURING THE WIRE EXCHANGE, AND THEY WERE UNABLE TO FLUSH THE SPONGE FROM THE CHANNEL. ALTHOUGH THE PROCEDURE WAS PROLONGED, IT WAS SUCCESSFULLY COMPLETED USING WITH ANOTHER OF 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 23991885 ↗
• MalfunctionOct 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. DURING THE PROCEDURE, WHEN THE PHYSICIAN USED RAT TOOTH FORCEPS TO RETRIEVE A STENT, BUT THE FORCEPS BECAME STUCK. UPON INVESTIGATION, IT WAS FOUND THAT THE FOAM INSERT FROM THE BIOPSY CAP HAD DISLODGED AND WAS LODGED INSIDE THE SCOPE. THE PROCEDURE WAS COMPLETED USING 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 23222449 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE SPONGE DETACHED IN THE WORKING CHANNEL OF THE SCOPE. A BORESCOPE WAS USED TO REMOVE THE SPONGE. THE PROCEDURE WAS COMPLETE USING AN ALTERNATE DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS 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 22771046 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025 THE SPONGE OF THE BIOPSY CAP BECAME LODGED IN THE DUODENOSCOPE. A WATER-SOLUBLE LUBRICANT TO THE TOP OF THE BIOPSY CAP, PRIOR TO USE. THE FOAM PIECE WAS RETRIEVED DURING SCOPE CLEANING AND STERILIZATION. REPORTEDLY, THE SCOPE HAD TO BE SENT FOR REPAIR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609633 ↗
• MalfunctionJul 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE DUODENOSCOPE COULD NO LONGER ASPIRATE DUE TO AN OBSTRUCTION IN THE CHANNEL. MULTIPLE ATTEMPTS WERE MADE IN THE OPERATING ROOM TO UNCLOG THE ENDOSCOPE; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. THE PROCEDURE WAS UNABLE TO BE COMPLETED AS A RESULT OF THIS EVENT. REPORTEDLY, A WATER-SOLUBLE LUBRICANT TO THE TOP OF THE BIOPSY CAP, PRIOR TO USE. THE FOLLOWING DAY, A RENEWED ATTEMPT TO CLEAR THE BLOCKAGE WAS MADE. AFTER SEVERAL MANEUVERS, THE OBSTRUCTION WAS SUCCESSFULLY REMOVED. THE OBSTRUCTION WAS IDENTIFIED AS A PIECE OF FOAM FROM THE BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22609568 ↗
• MalfunctionJun 26, 2025Use of Device Problem; Detachment of Device or Device Component; Material Integrity Problem; Use of Device Problem; Detachment of Device or Device Component; Material Integrity Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX LOCKING / BIOPSY CAP WAS USED IN THE BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025, FOR THE TREATMENT OF BILE DUCT STONES. DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO PASS A STONE-REMOVING BALLOON CATHETER THROUGH THE ENDOSCOPE'S WORKING CHANNEL. RESISTANCE WAS ENCOUNTERED, AND AN OBSTRUCTION WAS NOTED WITHIN THE CHANNEL. AS A RESULT, THE ENDOSCOPE WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE COULD NOT BE COMPLETED. REPORTEDLY, IT WAS DISCOVERED THAT A SPONGE WAS LODGED IN THE WORKING CHANNEL AND COULD NOT BE REMOVED. IT WAS ALSO NOTED THAT WATER-SOLUBLE LUBRICANT HAD NOT BEEN APPLIED TO THE TOP OF THE BIOPSY CAP PRIOR TO ITS USE. THE ENDOSCOPE WAS SUBSEQUENTLY SENT FOR REPAIR. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341508 ↗
• MalfunctionJun 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE ANTI-REFLUX FOAM DETACHED AND WENT INTO THE WORKING CHANNEL OF THE DUODENOSCOPE. THE PROCEDURE CONTINUED, HOWEVER, THE PHYSICIAN REPORTED THAT THE OBJECT DISPLACED INSIDE THE TUBE CAUSED RESISTANCE DURING THE PROCEDURE. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196517 ↗
• MalfunctionMay 27, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH STENT REMOVAL PROCEDURE PERFORMED ON (B)(6) 2025. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS INSTRUMENTS THROUGH THE WORKING CHANNEL OF THE SCOPE. THEY WERE ABLE TO PULL THE STENT USING A BIOPSY FORCEPS, HOWEVER, IT WAS VERY DIFFICULT TO PASS THE FORCEPS THROUGH THE CHANNEL. THE PHYSICIAN THEN ATTEMPTED TO PASS A SNARE THROUGH THE WORKING CHANNEL. THEY WERE UNABLE TO PASS THE SNARE AND SWITCHED TO A NEW SCOPE. DURING THE SCOPE CLEANING THEY COULD NOT GET THE CLEANING SOLUTION OR WATER TO SUCTION THROUGH THE WORKING CHANNEL. THE SPONGE FROM BIOPSY CAP WAS DISCOVERED TO BE OBSTRUCTING WORKING CHANNEL. REPORTEDLY, A WATER-SOLUBLE LUBRICANT WAS APPLIED ON TOP OF THE BIOPSY CAP PRIOR TO USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON MAY 28, 2025: IT WAS CONFIRMED THAT THE SPONGE DETACHED INTO THE SCOPE WORKING CHANNEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22087786 ↗
• MalfunctionFeb 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2025 FOR THE TREATMENT OF CANCER. DURING THE PROCEDURE, THE PHYSICIAN PULLED TWO STENTS OUT OF THE SCOPE AND THEN FLUSHED THE SCOPE WITH A BLUNT NEEDLE. IT WAS OBSERVED THAT THE SPONGE FROM THE BIOPSY CAP HAD DISLODGED INTO THE SCOPE. THE SPONGE WAS REMOVED USING RAT TOOTHED FORCEPS. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21298260 ↗
• MalfunctionJan 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN FELT RESISTANCE WHEN PASSING THE TOME THROUGH THE SCOPE AND NOTICED THE SPONGE INSIDE OF THE BIOPSY CAP WAS MISSING. RAT TOOTH FORCEPS WERE USED IN AN ATTEMPT TO RETRIEVE THE SPONGE, HOWEVER, IT REMAINED STUCK INSIDE THE SCOPE. A NEW SCOPE AND RX LOCKING DEVICE AND BIOPSY CAP WAS USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED ON THE BIOPSY CAP PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103476 ↗
• MalfunctionDec 2, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING A PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, IT WAS NOTICED THAT THE SPONGE DETACHED IN THE WORKING CHANNEL OF THE SCOPE WHEN THE PHYSICIAN ADVANCED THE TOME DEVICE THROUGH THE BIOPSY CAP. REPORTEDLY, EFFORTS TO RETRIEVE THE SPONGE FROM THE WORKING CHANNEL WAS UNSUCCESSFUL. AS A RESULT, THE SCOPE WAS UNABLE TO SUCTION DUE TO THE CHANNEL BEING OCCLUDED. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED ON THE BIOPSY CAP PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. NOTE: ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT CANNOT BE OBTAINED. AS PER MEDWATCH MDR REPORT# MW5160949, HEALTH CARE FACILITY AND ACCOUNT INITIAL REPORTER DETAILS WERE NOT PROVIDED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819219 ↗
• MalfunctionNov 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE ON (B)(6) 2024. DURING THE MIDDLE OF THE PROCEDURE, THE SPONGE IN THE BIOPSY CAP CAME OUT AND GOT STUCK IN THE SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT AFTER THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759773 ↗
• MalfunctionNov 6, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE AMPULLA FOR THE TREATMENT OF STRICTURE ON (B)(6) 2024. DURING THE PROCEDURE, THE PHYSICIAN BEGAN TO FEEL RESISTANCE WHILE PASSING ACCESSORIES THROUGH THE BIOPSY CAP. UPON FURTHER INSPECTION, THEY NOTICED THAT THE SPONGE FROM THE BIOPSY CAP WAS LODGED IN THE SCOPE. IT WAS RETRIEVED FROM THE SCOPE USING ALLIGATOR FORCEPS. REPORTEDLY, A WATER-SOLUBLE LUBRICANT WAS NOT APPLIED TO THE TOP OF THE BIOPSY CAP PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING 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 20620718 ↗
• MalfunctionOct 3, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT FOR THE TREATMENT OF DILATED COMMON BILE DUCT AND STONE REMOVAL ON (B)(6) 2024. DURING THE ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS INSTRUMENTS THROUGH THE WORKING CHANNEL OF THE SCOPE. THEY WERE ALSO UNABLE TO INSTILL CONTRAST VIA DREAMTOME. THEY SWITCHED TO A NEW SCOPE, WHICH WAS SUCCESSFULLY USED AFTER A FIFTEEN MINUTE DELAY. REPORTEDLY, DURING REPROCESSING, AN ENDO TECH DISCOVERED A SPONGE LODGED IN THE WORKING CHANNEL, IDENTIFIED AS PART OF THE RX LOCKING/BIOPSY CAP. THE FOAM PIECE WAS REMOVED BY PUSHING MULTIPLE BRUSHES DOWN THE BIOPSY CHANNEL. A WATER-SOLUBLE LUBRICANT WAS NOT APPLIED TO THE TOP OF THE BIOPSY CAP, PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20359266 ↗
• MalfunctionSep 27, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE PANCREAS FOR THE TREATMENT OF PANCREATIC CANCER ON (B)(6) 2024. DURING THE PROCEDURE, THE SPONGE WAS POPPING OUT OF THE LOCKING DEVICE. THE SPONGE DETACHED IN THE WORKING CHANNEL OF THE SCOPE WHEN THE TOME DEVICE WAS ADVANCE THROUGH THE BIOPSY CAP. REPORTEDLY, THE SPONGE WAS RETRIEVED USING FORCEPS. THE PROCEDURE WAS COMPLETE 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 20317349 ↗
• MalfunctionSep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT NUMBER 3005099803-2024-04635 FOR THE RX LOCKING / BIOPSY CAP AND REPORT NUMBER 3005099803-2024-04642 FOR THE DREAMWIRE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT RX LOCKING / BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE BILE DUCT FOR THE TREATMENT OF STONES. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO PASS THE DREAMWIRE DOWN THE SCOPE. SEVERAL INTERVENTIONS WERE ATTEMPTED; HOWEVER, IT WAS UNSUCCESSFUL. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE RESCHEDULED PROCEDURE WAS COMPLETED BY PERFORMING A LAPAROSCOPIC CHOLECYSTECTOMY. WHEN THE SCOPE WAS CHECKED THE FOLLOWING DAY, A PIECE OF FOAM FROM THE BIOPSY CAP WAS PULLED OUT OF THE WORKING PORT. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED ON THE BIOPSY CAP PRIOR TO USE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20271630 ↗
• MalfunctionSep 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE AND BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE POST PROCEDURE, WHEN BRUSHING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) SCOPE IN THE CLEANING ROOM, A SPONGE WAS REMOVED THAT LOOKS LIKE A BIOPSY CAP FOR THE LOCKING DEVICE. REPORTEDLY, THE SPONGE WAS RETRIEVED USING BIOPSY FORCEPS. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED ON THE BIOPSY CAP PRIOR TO USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20128095 ↗
• MalfunctionJun 13, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE BIOPSY CAP WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, THE INTERNAL FOAM CAME LOOSE AND STUCK INSIDE THE ENDOSCOPE CHANNEL. THE FOAM PIECE WAS RETRIEVED. A WATER-SOLUBLE LUBRICANT WAS NOT APPLIED ON THE BIOPSY CAP PRIOR TO USE. REPORTEDLY, THE SPONGE WAS DETACHED WHILE AN ADVANIX BILIARY PROSTHESIS BEING PASSED THROUGH THE CAP. THE PROCEDURE WAS COMPLETED USING ANOTHER VALVE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529404 ↗
• MalfunctionMay 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN RX LOCKING DEVICE BIOPSY CAP WAS USED IN THE AMPULLA DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2024, FOR THE TREATMENT OF BILIARY OBSTRUCTION. DURING THE PROCEDURE, THE FOAM FROM A LOCKING DEVICE DISLODGED AND BLOCKED THE SCOPE. THE FOAM PIECE WAS RETRIEVED USING A CLEANING BRUSH AND BIOPSY FORCEPS. A WATER-SOLUBLE LUBRICANT WAS APPLIED ON THE BIOPSY CAP PRIOR TO USE. 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 19271826 ↗