POWER DRIVE ART1 2304007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04055207012246), received between Feb 16, 2022 and Feb 18, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionFeb 18, 2022Display or Visual Feedback Problem; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Display or Visual Feedback Problem; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO RICHARD WOLF: "(B)(6) CALLED (B)(4), THE LOCAL REP, DURING THE PROCEDURE. WHEN THE FOOTSWITCH FOR THE POWERDRIVE ART1 WAS ACTIVATED, THE CONTROLLER DISPLAYED A "FOOTPEDAL DEFECTIVE" ERROR MESSAGE. THE REP ASKED THEM TO DISCONNECT AND RE-CONNECT THE FOOTSWITCH, AND THE MESSAGE WAS NO LONGER DISPLAYED. WHEN THEY STARTED THE PROCEDURE, THE HANDPIECE WASN'T ROTATING THE BURR. THEY DISCONNECTED THE CABLE FROM THE HANDPIECE AND GENERATOR, AND RE-CONNECTED. THE HANDPIECE STILL WOULD NOT ROTATE THE BURR. THEN THE REP CALLED ME TO CONFERENCE WITH THE OPERATING ROOM, AND THAT'S WHEN THE PHYSICIAN STOPPED THE CASE. HE HAD MADE AN INCISION, STOPPED THE CASE, CLOSED THE INCISION, AND WILL RE-SCHEDULE. CHRIS, THE LOCAL SALES REP WENT TO THE ACCOUNT AND DETERMINED THAT THE (2) 89955.0000 M4 MOTOR HANDPIECES AND THE 8564.851 CONNECTING CABLE WERE FUNCTIONING PROPERLY, AND WILL NOT BE RETURNED TO US FOR EVALUATION." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED IS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13559175 ↗
• InjuryFeb 16, 2022Display or Visual Feedback Problem; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available; Display or Visual Feedback Problem; Device Displays Incorrect Message; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO RICHARD WOLF: "(B)(6) CALLED (B)(6) , THE LOCAL REP, DURING THE PROCEDURE. WHEN THE FOOTSWITCH FOR THE POWERDRIVE ART1 WAS ACTIVATED, THE CONTROLLER DISPLAYED A "FOOTPEDAL DEFECTIVE" ERROR MESSAGE. THE REP ASKED THEM TO DISCONNECT AND RE-CONNECT THE FOOTSWITCH, AND THE MESSAGE WAS NO LONGER DISPLAYED. WHEN THEY STARTED THE PROCEDURE, THE HANDPIECE WASN'T ROTATING THE BURR. THEY DISCONNECTED THE CABLE FROM THE HANDPIECE AND GENERATOR, AND RE-CONNECTED. THE HANDPIECE STILL WOULD NOT ROTATE THE BURR. THEN THE REP CALLED ME TO CONFERENCE WITH THE OPERATING ROOM, AND THAT'S WHEN THE PHYSICIAN STOPPED THE CASE. HE HAD MADE AN INCISION, STOPPED THE CASE, CLOSED THE INCISION, AND WILL RE-SCHEDULE. (B)(6) , THE LOCAL SALES REP WENT TO THE ACCOUNT AND DETERMINED THAT THE (2) 89955.0000 M4 MOTOR HANDPIECES AND THE 8564.851 CONNECTING CABLE WERE FUNCTIONING PROPERLY, AND WILL NOT BE RETURNED TO US FOR EVALUATION." WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED ON A PATIENT WHEN THE REPORTING ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13542837 ↗