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Viper 70338020Recalls & reported problems

Gyrus ACMI, LLC · VIPER DRILL HANDPIECE STRAIGHT FOR DIEGO CONSOLE · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00821925011465), received between Nov 1, 2021 and Nov 1, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Split, Cut or Torn1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 1, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

    AS REPORTED, THE DEVICE CORD THAT ATTACHED TO THE DRILL WAS FOUND WITH A CUT. THE ISSUE FOUND DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED ON THIS REPORTED EVENT. NO USER INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 12734112 ↗

Other DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices

All DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE devices →

Sources and updates

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