ACS EVRB95HRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072215130), received between Oct 31, 2024 and Oct 31, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Contamination” (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 16, 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.

• InjuryOct 31, 2024Contamination; Contamination

  IT WAS REPORTED THAT BLUE FIBERS WERE FOUND ON PATIENT'S SKIN AND IN THE SURGICAL SITE (ABDOMEN) DURING SURGERY. ADDITIONAL INFORMATION WAS RECEIVED ON OCTOBER 14, 2024, THE CUSTOMER RESPONDED THE SURGERY WAS A ROBOTIC HYSTERECTOMY. THE FIBERS WERE IRRIGATED AND SUCTIONED FROM SITE/SKIN WITH NO OTHER IMPACT REPORTED. ADDITIONAL INFORMATION WAS REQUESTED TO GET COMPONENT INFORMATION FROM THE CUSTOMER ON OCTOBER 11, 2024, OCTOBER 14, 2024, AND OCTOBER 15, 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20580081 ↗