Valleylab E4055-CTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884524000787), received between Mar 25, 2020 and Jul 18, 2023 — classified as 1 injury, 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO THE LITERATURE, A PROSPECTIVE STUDY AIMED TO COMPARE THE OUTCOMES AFTER BIPOLAR ELECTROCAUTERY TONSILLECTOMY VERSUS COBLATION TONSILLECTOMY IN PEDIATRIC PATIENTS, AGE 3-12, BETWEEN FEBRUARY AND AUGUST 2022. A TOTAL OF 120 PATIENTS WERE RANDOMLY DIVIDED INTO TWO EQUAL GROUPS. SIXTY PATIENTS UNDERWENT COBLATION TONSILLECTOMY WITH A COMPETITOR DEVICE AND SIXTY PATIENTS UNDERWENT BIPOLAR ELECTROCAUTERY TONSILLECTOMY USING FORCE FX WITH STRAIGHT BIPOLAR FORCEPS WITH THE DEVICE SET AT 40 FOR BOTH DISSECTION AND CAUTERIZATION. ALL PATIENTS HAD THE PROCEDURE DONE UNDER GENERAL ANESTHESIA AND ORAL ENDOTRACHEAL INTUBATION. ACETAMINOPHEN AND IBUPROFEN WERE USED FOR PAIN CONTROL AND ANTIBIOTICS WERE GIVEN IN. ON THE LAST VISIT, THE OVERALL PAIN SCALE WAS SCORED OVER 40 REPRESENTED THE WORST PAIN SCALE (THE TOTAL NUMBER OF 4 VISITS). SIX PATIENTS IN THE BIPOLAR GROUP EXPERIENCED POSTOPERATIVE BLEEDING OR HEMORRHAGE. TWO PATIENTS BLED AFTER 24 H (REACTIONARY), TWO AFTER 48 H (REACTIONARY), ONE AFTER 4 DAYS (SECONDARY), AND ONE AFTER 1 WEEK (SECONDARY). ALL OF THEM WERE ADMITTED TO THE HOSPITAL, AND THE BLEEDING WAS CONTROLLED BY CONSERVATIVE METHODS. NONE OF THEM NEEDED REOPERATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Pain

  MAUDE report 17346029 ↗
• MalfunctionJul 20, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE DEVICE HAD AN INSULATION ISSUE WHEREIN IT FELL APART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199887 ↗
• MalfunctionJun 8, 2021Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, POST OPERATIVELY, THE DEVICE INSULATION WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11962786 ↗
• MalfunctionMar 25, 2020Separation Problem; Separation Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, TISSUE ADHESION TO THE TIP OF THE FORCEPS WAS TOO MUCH, AND RE BLEEDING OCCURRED. OOZING BLEEDING OCCURRED AS A RESULT OF THE ISSUE. THERE WAS NO TISSUE DAMAGE AND INCISION SITE WAS NOT EXTENDED. THEY USED ANOTHER LIKE DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876453 ↗