ENDOCAM 85525922Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04055207027387), received between Mar 1, 2019 and Apr 4, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property 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. How this data works · Data updated Oct 13, 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.

• MalfunctionApr 4, 2022No Display/Image; No Display/Image

  THE USER HAS REPORTED THE FOLLOWING INFORMATION (TRANSLATED FROM FRENCH): 43-YEAR-OLD PATIENT BENEFITING FROM AN EXPLORATORY LAPAROSCOPY FOLLOWING A STAB WOUND. DURING THE INTERVENTION, THE TEAM NOTICES A LOSS OF IMAGE FROM THE CAMERA. THEY HAVE CHANGED THE ENTIRE VIDEO COLUMN (INCOMPATIBLE CAMERA FROM ONE COLUMN TO ANOTHER) IMPACTING THE ORGANIZATION AND MANAGEMENT OF THE PATIENT (INCREASE IN OPERATING TIME). RISK OF CONVERSION FROM OPEN SURGERY. EXTENSION OF OPERATING TIME 20 MINUTES. THEY HAVE CHANGED THE DEVICE AND COULD HAVE COMPLETED THE PROCEDURE. ADDITIONAL INFORMATION FROM THE MANUFACTURER: THE PATIENT HAD A STAB WOUND, SO THEY WERE CHECKING IF A TISSUE REPAIR IS NEEDED. THE USER FACILITY DID NOT REPORTED THAT THEY HAD TO REPAIR ANY TISSUE DUE TO THE FAILURE OF THE CAMERA HEAD OR THE PATIENT WAS INJURIED BY THE FAILURE. THEIR ONLY CONCERN WAS THE 20-MINUTE-DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13995124 ↗
• MalfunctionOct 23, 2020Overheating of Device; Overheating of Device

  PLEASE SEE MANUFACTURERS NARRATIVE FOR THE RESULTS OF THE DEVICE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10728904 ↗
• MalfunctionMar 1, 2019Electrical /Electronic Property Problem; Optical Problem; Electrical /Electronic Property Problem; Optical Problem

  THE PURPOSE OF THIS SUBMISSION IS TO REPORT THE RESULTS OF THE DEVICE INVESTIGATION. SEE MANUFACTURERS NARRATIVE (H10).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382937 ↗