FUJIFILM DH-28GRRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04547410331653), received between May 8, 2023 and Nov 1, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 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 WITH DH-28GR. IT WAS REPORTED THAT THE HOOD SEPARATED AND FELL INTO THE GASTROINTESTINAL TRACT. THE PIECE WAS RETRIEVED AND A NEW HOOD WAS ATTACHED TO THE ENDOSCOPE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18046101 ↗
• InjuryNov 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE HOOD SEPARATED AND FELL INTO THE GASTROINTESTINAL TRACT. THE PIECE WAS RETRIEVED AND A NEW HOOD WAS ATTACHED TO THE ENDOSCOPE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT HARM OR INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18046062 ↗
• MalfunctionJul 26, 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 DH-28GR. IT WAS REPORTED THAT THE HOOD SEPARATED AND FELL INTO THE GASTROINTESTINAL TRACT DURING INSERTION. 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 17396383 ↗
• InjuryJul 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING DH-28GR. IT WAS REPORTED THAT THE HOOD SEPARATED AND FELL INTO THE GASTROINTESTINAL TRACT DURING INSERTION. 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 17341892 ↗
• 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). IT WAS REPORTED THAT THE TIP OF THE DEVICE FELL OFF WHEN THE SCOPE WAS REMOVED AFTER PERFORMING A SUBMUCOSAL DISSECTION. THE PIECES WERE 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 16930273 ↗
• InjuryMay 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ON APRIL 14, 2023, FUJIFILM CORPORATION WAS INFORMED OF AN EVENT INVOLVING DH-28GR. IT WAS REPORTED THAT THE TIP OF THE DEVICE FELL OFF WHEN THE SCOPE WAS REMOVED AFTER PERFORMING A SUBMUCOSAL DISSECTION. THE PIECES WERE 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 16892108 ↗