FUJIFILM DH-30CRRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04547410331677), received between Apr 27, 2023 and May 15, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING (B)(4). THIS REPORT ADDRESSES THE FIRST OF TWO CASES THAT OCCURRED ON THE SAME DAY AT THE SAME FACILITY. IT WAS REPORTED THAT DURING A COLONOSCOPY, THE HOOD SEPARATED AT THE JUNCTION OF ITS TWO SECTIONS WHILE ATTACHED TO THE ENDOSCOPE AND FELL INTO THE GASTROINTESTINAL TRACT. THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY. THERE WAS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16930277 ↗
• MalfunctionMay 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON APRIL 21, 2023, FUJIFILM HEALTHCARE AMERICAS CORPORATION WAS INFORMED OF AN EVENT INVOLVING DH-30CR. THIS REPORT ADDRESSES THE SECOND OF TWO CASES THAT OCCURRED ON THE SAME DAY AT THE SAME FACILITY. IT WAS REPORTED THAT DURING A COLONOSCOPY, THE HOOD SEPARATED AT THE JUNCTION OF ITS TWO SECTIONS WHILE ATTACHED TO THE ENDOSCOPE AND FELL INTO THE GASTROINTESTINAL TRACT. THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY. THERE WAS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16930275 ↗
• InjuryApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON APRIL 17, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING DH-30CR. THIS REPORT ADDRESSES THE FIRST OF TWO CASES THAT OCCURRED ON THE SAME DAY AT THE SAME FACILITY. IT WAS REPORTED THAT DURING A COLONOSCOPY, THE HOOD SEPARATED AT THE JUNCTION OF ITS TWO SECTIONS WHILE ATTACHED TO THE ENDOSCOPE AND FELL INTO THE GASTROINTESTINAL TRACT. THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY. THERE WAS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16828513 ↗
• InjuryApr 27, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON APRIL 17, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING DH-30CR. THIS REPORT ADDRESSES THE SECOND OF TWO CASES THAT OCCURRED ON THE SAME DAY AT THE SAME FACILITY. IT WAS REPORTED THAT DURING A COLONOSCOPY, THE HOOD SEPARATED AT THE JUNCTION OF ITS TWO SECTIONS WHILE ATTACHED TO THE ENDOSCOPE AND FELL INTO THE GASTROINTESTINAL TRACT. THE PIECE WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY. THERE WAS NO DEATH REPORTED WITH THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16828508 ↗