Geenen G21803Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002218031), received between Mar 31, 2026 and Jul 20, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 18, 2026.

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.

• InjuryJul 20, 2026Migration

  THE DOCTOR WAS UNABLE TO FIT THE PROSTHESIS INTO THE CANAL. IT DETACHED AND FELL INTO THE DIGESTIVE TRACT, UNFORTUNATELY NOT RECOVERABLE. THE PRACTITIONER DEPLOYED THE STENT IN BAD POSITION AND LOST THE STENT IN THE DUODENUM. THE DOCTOR DID NOT SUCCEED IN PROPERLY INSERTING THE STENT INTO THE CANAL. IT DETACHED AND FELL INTO THE DIGESTIVE TRACT; UNFORTUNATELY, IT CANNOT BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25881373 ↗
• MalfunctionMar 31, 2026Improper or Incorrect Procedure or Method

  DURING AN INITIAL EXAMINATION, THE PROSTHESIS COVER BECAME LODGED IN THE ENDOSCOPE (NOT DETECTED AT THE TIME OF THE EXAMINATION). DESPITE CAREFUL HANDLING IN THE ENDOSCOPE PROCESSING AREA, THE AGENTS DID NOT DETECT ITS PRESENCE IN THE ENDOSCOPE (SWABBING DONE NORMALLY, PASSING THROUGH THE MACHINE WITHOUT ERROR). DURING THE NEXT EXAMINATION, THE STENT PROTECTOR WAS RELEASED INTO THE PATIENT'S BODY; THE ENDOSCOPY NURSES NOTICED IT IMMEDIATELY AND IT WAS ABLE TO BE REMOVED. DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED = NOT REMOVED FROM THE PATIENT BUT FROM THE ENDOSCOPE. 1. PLEASE DESCRIBE THE STORAGE CONDITIONS OF THE DEVICE PRIOR TO USE ESPECIALLY THOSE PERTAINING TO TEMPERATURE AND LIGHT EXPOSURE. ANS. STORED AWAY FROM LIGHT, AT ROOM TEMPERATURE IN A ROOM DESIGNATED FOR MEDICAL DEVICES. 2. WHAT IS THE REORDER NUMBER, DIAMETER AND LENGTH OF THE WIRE GUIDE THAT WAS USED WITH THIS DEVICE IN THIS PROCEDURE? ANS. OLYMPUS WIRE 0.25 AND 450 CM. 3. WAS THE WIRE GUIDE LUBRICATED PRIOR TO USE? ANS. YES WITH PHY SERUM. 4. WAS THE WIRE GUIDE INSPECTED FOR DAMAGE PRIOR TO USE? ANS. YES INSPECTED, NO DAMAGE. 5. WAS THE DEVICE AT THE CENTRE OF THE COMPLAINT INSPECTED FOR DAMAGE PRIOR TO USE? ANS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24743366 ↗