Valleylab E4054-CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884524000770), received between Jun 12, 2019 and Jun 21, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 21, 2019Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE FORCEPS JAW WAS BURNT. A PIECE DETACHED FROM THE DEVICE BUT DID NOT FALL INTO THE PATIENT'S CAVITY, IT WAS SEEN POST-OPERATIVELY. THE PIECE WILL BE RETURNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724634 ↗
• MalfunctionJun 12, 2019Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, AFTER FIRST USE, THE DEVICE HAD AN INSULATION ISSUE WHERE IN THE CLAMP UNLOCKED ALL COATING. NO PART OF THE DEVICE COMPLETELY DISENGAGED. THE EVENT OCCURRED DURING THE SURGERY BUT WAS ONLY NOTICED POST-OPERATIVELY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 8690228 ↗