NA 8834075Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207043356), received between Mar 30, 2023 and Mar 30, 2023 — 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. How this data works · Data updated Oct 13, 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.

• MalfunctionMar 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A USER FACILITY REPRESENTATIVE HAS INFORMED RICHARD WOLF GMBH AN ISSUE REGARDING A RECTOSCOPE TUBE Ø 19MM WL 211MM, PART ID: 8834075, BATCH # 1446330. ACCORDING TO THE RECEIVED INFORMATION: "WHEN RETRACTING THE RECTOSCOPE DURING EXAMINATION, THE METAL END PIECE CAME LOOSE AND GOT STUCK IN THE RECTUM. REMOVAL OF THE END PIECE WITH PROCTOSCOPE, FORCEPS AND NEEDLE HOLDER BY DETACHING THE END PIECE. THE PROCEDURE COULD NOT BE COMPLETED DUE TO DEFECTIVE DEVICE." ACCORDING TO THE USER, THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644204 ↗