NA COVSCD396Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10888551008020), received between Jun 4, 2019 and Jun 5, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2019Smoking; Detachment of Device or Device Component; Smoking; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE WITH A SONICISION CORDLESS ULTRASONIC DISSECTOR AND THE TIP OF DEVICE BEGAN SMOKING AND A PIECE OF THE TIP DETACHED DURING PROCEDURE. THE WHITE COATING ON THE TIP OF THE DEVICE STARTED TO COME APART DURING USE AND POSSIBLY MELTED OFF. TINY FRAGMENT OF WHITE PLASTIC COATING COMPLETELY DETACHED INSIDE OF THE PATIENT. TIP OF INSTRUMENT LOOKED CHARRED. ALL VISIBLE MATERIAL WAS RETRIEVED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672133 ↗
• MalfunctionJun 4, 2019Thermal Decomposition of Device; Smoking

  DURING CASE, STERILMED SONICISION CORDLESS ULTRASONIC DISSECTOR BEGAN TO SMOKE. THE PLASTIC PIECE THAT IS ON THE TIP OF THE DISSECTOR BEGAN TO DETERIORATE. ITEM IMMEDIATELY TAKEN OUT OF USE. NO HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8666420 ↗