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NA 72200872FRecalls & reported problems

Smith & Nephew, Inc. · DYONICS POWERMAX ELITE HANDPIECE HAND-CONTROLLED WITH OPPOSITE-SIDE SUCTION LEVER REFURBISHED · Class 1

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 00885554028973), received between Feb 5, 2018 and Feb 5, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Overheating of Device” (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

  • Overheating of Device1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • MalfunctionFeb 5, 2018Overheating of Device

    IT WAS REPORTED AN OVERHEATING HANDPIECE. NO CASE REPORTED. NO PATIENT INJURIES WERE REPORTED.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 7241691 ↗

Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices

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Sources and updates

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