RX Locking Device and Biopsy Cap M00545280Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08714729746690), received between Aug 2, 2021 and Aug 2, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 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 THE BILIARY SYSTEM DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) , 2021. DURING THE PROCEDURE, A SNARE WAS PASSED THROUGH THE BIOPSY CAP TO REMOVE A STENT FROM THE BILIARY SYSTEM. ONCE THE STENT WAS REMOVED, THE PHYCIAN ATTEMPTED TO PASS AN EXTRACTOR BALLOON THROUGH THE BIOPSY CHANNEL ; HOWEVER, THE DEVICE WAS UNABLE TO PASS DUE TO RESISTANCE. A WATER SOLUBLE LUBRICANT WAS NOT APPLIED TO THE RX LOCKING DEVICE BIOPSY CAP PRIOR TO USE. THE SCOPE WAS SENT FOR REPROCESSING TO REMOVE THE SPONGE. THE PROCEDURE WAS COMPLETED USING ANOTHER SCOPE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12258757 ↗