NA 03.809.825Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034726151), received between Sep 5, 2023 and Sep 5, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionSep 5, 2023Contamination /Decontamination Problem; Material Integrity Problem; Contamination /Decontamination Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, DURING THE CLEANING PROCESS, IT WAS MENTIONED THAT DISCOLORATIONS HAVE RECENTLY APPEARED ON THE INSTRUMENTS. THE DISCOLORATIONS ONLY OCCUR ON THE ¿GOLD-PLATED¿ PARTS OF THE INSTRUMENTS. THERE WAS NO PATIENT OR SURGERY INVOLVEMENT. THIS REPORT INVOLVES ONE PADDLE SHAVER 15MM HEIGHT. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681803 ↗