NA 72200095Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010555694), received between Aug 16, 2017 and Jan 13, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Flaked” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, WHEN THE INCISOR PLUS ELITE BLADE WAS ACTIVATED, METAL FLAKES MADE FROM THE INNER BLADE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9583195 ↗
• MalfunctionJan 13, 2020Flaked; Flaked

  IT WAS REPORTED THAT DURING THE PROCEDURE, WHEN THE BLADE WAS ACTIVATED, METAL FLAKES WERE MADE FROM THE INNER BLADE. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO PATIENT INJURIES OR DELAY REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9580620 ↗
• MalfunctionNov 5, 2019Flaked; Flaked

  IT WAS REPORTED THAT DURING A SURGERY THE SHAVER BLADE EXPELLED SOME METAL DEBRIS UPON ACTIVATION, IT WAS NOTICED A SQUEAKY SOUND UPON ASSESSMENT. IT IS UNKNOWN IF THERE WAS AN AVAILABLE BACK-UP DEVICE OR A SIGNIFICANT DELAY DURING THE PROCEDURE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9281524 ↗
• MalfunctionApr 23, 2019Smoking; Noise, Audible

  IT WAS REPORTED THAT THE BLADE MADE A NOISE AND RELEASED SMOKE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8542065 ↗
• MalfunctionAug 16, 2017Metal Shedding Debris

  IT WAS REPORTED THAT WHEN THE BLADE WAS ACTIVATED, METAL FLAKES SHED FROM THE INNER BLADE. NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6799364 ↗