RX Locking Device and Biopsy Cap M00545270Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08714729746683), received between Jan 8, 2020 and May 10, 2023 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2023Use 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 A RX LOCKING / BIOPSY CAP WAS TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2023. DURING THE PROCEDURE, WHILE PASSING A HYDRATOME 44, THE WHITE SPONGE WITHIN THE TRANSPARENT BIOPSY CAP WAS DISLODGED IN THE SCOPE. THE SPONGE WAS SUCCESSFULLY REMOVED FROM THE SCOPE WITH FORCEPS. A WATER SOLUBLE LUBRICANT WAS NOT APPLIED TO THE RX LOCKING DEVICE BIOPSY CAP PRIOR TO USE. ANOTHER RX LOCKING / BIOPSY CAP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16902733 ↗
• MalfunctionMay 9, 2023Use 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 A RX LOCKING / BIOPSY CAP WAS TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2023. DURING THE PROCEDURE, WHILE PASSING A HYDRATOME 44, THE WHITE SPONGE WITHIN THE TRANSPARENT BIOPSY CAP WAS DISLODGED IN THE SCOPE. THE SPONGE WAS SUCCESSFULLY REMOVED FROM THE SCOPE WITH FORCEPS. A WATER SOLUBLE LUBRICANT WAS NOT APPLIED TO THE RX LOCKING DEVICE BIOPSY CAP PRIOR TO USE. ANOTHER RX LOCKING / BIOPSY CAP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16895576 ↗
• MalfunctionMay 8, 2023Use 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 A RX LOCKING / BIOPSY CAP WAS TO BE USED IN THE DUODENUM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) ON (B)(6) 2023. DURING THE PROCEDURE, WHILE PASSING A HYDRATOME 44, THE WHITE SPONGE WITHIN THE TRANSPARENT BIOPSY CAP WAS DISLODGED IN THE SCOPE. THE SPONGE WAS SUCCESSFULLY REMOVED FROM THE SCOPE WITH FORCEPS. A WATER SOLUBLE LUBRICANT WAS NOT APPLIED TO THE RX LOCKING DEVICE BIOPSY CAP PRIOR TO USE. ANOTHER RX LOCKING / BIOPSY CAP WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891175 ↗
• MalfunctionJun 14, 2021Use 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 A BIOPSY CAP WAS USED IN BILIARY DUCTS DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. DURING THE PROCEDURE, A SNARE WAS PASSED THROUGH THE BIOPSY CAP AND ONE OF THE PIECES INSIDE OF THE CAP WENT INTO THE WORKING CHANNEL AND WAS VERY DIFFICULT TO REMOVE THE DETACHED COMPONENT. REPORTEDLY, A WATER SOLUBLE LUBRICANT WAS NOT PLACED ON THE BIOPSY CAP PRIOR TO USE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DUODENOSCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11995783 ↗
• MalfunctionApr 5, 2021Use 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 A RX LOCKING / BIOPSY CAP WAS USED IN DURING A ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2021. POST PROCEDURE, THE SPONGE WAS FOUND INSIDE THE SCOPE WHICH BLOCKED THE WORKING CHANNEL. A WATER SOLUBLE LUBRICANT WAS NOT PLACED ON THE BIOPSY CAP PRIOR TO USE. THE SPONGE WAS SUCCESSFULLY REMOVED FROM THE SCOPE CHANNEL USING A RADIAL JAW. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT RX LOCKING / BIOPSY CAP. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11612744 ↗
• MalfunctionNov 16, 2020Detachment of Device or Device Component; Difficult to Advance; Detachment of Device or Device Component; Difficult to Advance

  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 AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THERE WAS DIFFICULTY PASSING A SPHINCTEROTOME THROUGH THE BIOPSY CAP CAUSING THE SPONGE TO DETACH AND WAS PUSHED INSIDE THE SCOPE CHANNEL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10843589 ↗
• MalfunctionJan 8, 2020Detachment 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 DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD TROUBLE ADVANCING A TOME THROUGH THE BIOPSY CHANNEL OF THE SCOPE. THE TOME AND BIOPSY CAP WERE REMOVED. ANOTHER RX LOCKING DEVICE BIOPSY CAP AND THE ORIGINAL TOME WERE USED TO COMPLETE THE PROCEDURE. IT IS UNKNOWN IF A WATER-SOLUBLE LUBRICANT WAS APPLIED TO THE RX LOCKING DEVICE BIOPSY CAP PRIOR TO USE. REPORTEDLY, UPON INSPECTION, POST PROCEDURE, THE SPONGE FROM THE ORIGINAL RX LOCKING DEVICE WAS FOUND TO HAVE DETACHED AND WAS STUCK IN THE SCOPE CHANNEL. THAT SPONGE WAS REMOVED FROM THE SCOPE USING BIOPSY FORCEPS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9564034 ↗