Scope Buddy EFA-US-GRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00677964063640), received between Feb 23, 2017 and Jun 17, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2021Smoking; Smoking

  THE USER FACILITY REPORTED THAT THEIR SCOPE BUDDY PLUS ENDOSCOPE FLUSHING AID BEGAN EMITTING SMOKE DURING A CYCLE AND SUBSEQUENTLY SHUT OFF. THERE WAS NO REPORT OF USER OR PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12021387 ↗
• MalfunctionMar 1, 2021Fire; Fire

  THE USER FACILITY REPORTED THAT THEIR SCOPE BUDDY UNIT BEGAN EMITTING FLAMES DURING A CYCLE. THE FIRE WAS EXTINGUISHED AND THERE WAS NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11391993 ↗
• InjuryFeb 23, 2017Device Reprocessing Problem; Device Reprocessing Problem

  THE CASE STATES THE FACILITY WAS NOT PROPERLY MANUALLY CLEANING ENDOSCOPE PRIOR TO PLACEMENT IN AER, POTENTIAL FOR PATIENT CROSS-CONTAMINATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6353711 ↗