Jagtome RX 39 M00573090Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729776550), received between May 20, 2020 and Dec 14, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Dec 22, 2021Class IIOpen, Classified

   Sterility of device is compromised due to a sterile barrier breach

   Z-0769-2022 · Root cause: Packaging process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2020Break; Use of Device Problem; Break; Use of Device Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS USED IN THE COMMON BILE DUCT (CBD) DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH DOUDENAL PAPILLOTOMY AND ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) PROCEDURE PERFORMED ON (B)(6), 2020. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CUTTING WIRE BROKE AFTER ENERGIZATION. REPORTEDLY, THE DEVICE WAS ENERGIZED WHEN NOT IN CONTACT WITH TISSUE. ADDITIONALLY, NO PART OF THE CUTTING WIRE DETACHED AND FELL INTO THE PATIENT.THE PROCEDURE WAS COMPLETED WITH ANOTHER MANUFACTURER'S DEVICE. 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 Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11002435 ↗
• MalfunctionMay 20, 2020Break; Failure to Fold; Break; Failure to Fold

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGTOME RX 39 WAS TO BE USED IN THE BILIARY TRACT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, A BREAK IN THE CUTTING WIRE WAS OBSERVED AND THE DEVICE WOULD NOT BOW. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGTOME RX 39. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10076516 ↗