aScope™ Gastro 483001000USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05707480148172), received between May 27, 2026 and May 27, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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 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.

• InjuryMay 27, 2026Leak/Splash

  THE AMBU SYSTEM HAS BEEN LEAKING. THE PATIENT ASPIRATED AND THE PHYSICIAN DOESN'T WANT TO USE IT ANYMORE. PATIENT CONDITION WAS NOT AFFECTED, AND IS FINE NO PATIENT HARM AT TIME OF INCIDENT OR RESIDUALLY AFTERWARDS. FOLLOWING ADDITIONAL INFORMATION RECEIVED: WAS THE ENDOSCOPE INSPECTED FOR LEAKS OR WATER DRIPPING PRIOR TO INSERTION? IF SO, WHAT WAS OBSERVED? THERE WAS NOT ANY PREINSPECTION OF LEAKS OR DRIPPING PRIOR TO INSERTION. IT WAS DESCRIBED THAT WATER WAS FLOWING OUT LIKE A POWERFUL STREAM DURING PROCEDURE AND CONTINUED UPON EXTUBATION. AFTER PROCEDURE, NO APPARENT LEAKS WERE OBSERVED. FLUID WAS EXITING THROUGH THE FORWARD WATER JET CHANNEL. WAS ANY INTERVENTION REQUIRED BECAUSE OF THE LEAK (E.G. SUCTION), OR DID THE PATIENT CLEAR THE AIRWAY SPONTANEOUSLY BY COUGHING? NO SERIOUS INTERVENTION REQUIRED. JUST SUCTIONING THE AIRWAY FROM ANESTHESIA. AIRWAY WAS CLEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25303353 ↗
• InjuryMay 27, 2026Leak/Splash

  THE AMBU SYSTEM HAS BEEN LEAKING. THE PATIENT ASPIRATED AND THE PHYSICIAN DOESN'T WANT TO USE IT ANYMORE. PATIENT CONDITION WAS NOT AFFECTED, AND IS FINE NO PATIENT HARM AT TIME OF INCIDENT OR RESIDUALLY AFTERWARDS. FOLLOWING ADDITIONAL INFORMATION RECEIVED: WAS THE ENDOSCOPE INSPECTED FOR LEAKS OR WATER DRIPPING PRIOR TO INSERTION? IF SO, WHAT WAS OBSERVED? THERE WAS NOT ANY PRE-INSPECTION OF LEAKS OR DRIPPING PRIOR TO INSERTION. IT WAS DESCRIBED THAT WATER WAS FLOWING OUT LIKE A POWERFUL STREAM DURING PROCEDURE AND CONTINUED UPON EXTUBATION. AFTER PROCEDURE, NOT APPARENT LEAKS WERE OBSERVED. FLUID WAS EXITING THROUGH THE FORWARD WATER JET CHANNEL. WAS ANY INTERVENTION REQUIRED BECAUSE OF THE LEAK (E.G. SUCTION), OR DID THE PATIENT CLEAR THE AIRWAY SPONTANEOUSLY BY COUGHING? NO SERIOUS INTERVENTION REQUIRED. JUST SUCTIONING THE AIRWAY FROM ANESTHESIA. AIRWAY WAS CLEARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296331 ↗