Edge E1452Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884521713390), received between Oct 24, 2020 and Oct 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Cut” (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.

• MalfunctionOct 24, 2020Failure to Cut; Adverse Event Without Identified Device or Use Problem; Failure to Cut; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE PENCIL WAS NOT CUTTING AS IT TYPICALLY DID AND WAS SLOW AND INADEQUATE. CORDS WERE CHECKED, AND IT WAS OBSERVED THAT THE TONES DID NOT SOUND LIKE THE USUAL PENCIL DURING ACTIVATION. THE SURGEON TRIED TO CONTINUE WITH PROCEDURE, BUT WAS NOT GETTING TISSUE EFFECT AND ASKED TO HAVE CUT/COAG TURNED UP FROM 25/25 (TYPICAL SETTING) TO 40/40. THE ISSUE PERSISTED AND THE OTHER TIP WAS OPENED AND INSERTED IN ORIGINAL PENCIL WITH SAME RESULTS. THE SURGEON FINISHED THE PROCEDURE WITH THE 2ND TIP NOT FUNCTIONING/CUTTING WELL, AT A SETTING OF 40/40. THE PATIENT DEVELOPED A HEMATOMA POST OPERATIVELY WHICH WAS OBSERVED AT CHECK UP. THE PATIENT HAD A BLEEDING LESS THAN 250CC AND DEVELOPED A HEMATOMA POST OP WHICH WAS OBSERVED AT FIRST POST OP CHECK UP.

  Patient problems: Hematoma

  MAUDE report 10731715 ↗