NA 40712035Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04048551409954), received between Aug 19, 2025 and Sep 30, 2026 — classified as 28 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (13 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954093 ↗
• MalfunctionSep 30, 2026Output Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954090 ↗
• MalfunctionSep 30, 2026Mechanical Jam

  It was reported "Getting jammed during surgery". No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942505 ↗
• MalfunctionSep 30, 2026Output Problem

  It was reported "When the rotation speed was set to 6,000 rpm and the device was run idle 5 to 6 times as instructed, the error message "E19: Motor stopped M1" was displayed, and we were able to confirm the phenomenon where the motor rotation stopped.". No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50942358 ↗
• MalfunctionAug 13, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50236881 ↗
• MalfunctionAug 5, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50150328 ↗
• MalfunctionJul 30, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50091721 ↗
• MalfunctionJul 30, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50088014 ↗
• MalfunctionJul 27, 2026Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017321 ↗
• MalfunctionJun 26, 2026Mechanical Jam

  IT WAS REPORTED THAT THE DRILLCUT INTERMITTENTLY FREEZES DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25641663 ↗
• MalfunctionJun 5, 2026Intermittent Energy Output

  IT WAS REPORTED MOTOR DEFECTIVE. CONTACT KARL STORZ SERVICE, FUNCTION OUTAGES AT HIGHER SPEEDS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25416059 ↗
• MalfunctionFeb 4, 2026Mechanical Jam

  IT WAS REPORTED THAT "WHEN THE BLADE IS CONNECTED, THE ROTATION SOMETIMES BECOMES UNSTABLE OR STOPS AT BOTH LOW AND HIGH SPEED SETTINGS." IT WAS CONFIRMED THAT NO PATIENT WAS INVOLVED OR AFFECTED BY THIS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24262161 ↗
• MalfunctionJan 22, 2026Output Problem

  THE FOLLOWING WAS REPORTED: "THE MOTOR IS NOT ACTIVATING CONSISTENTLY WHEN THE FOOTSWITCH IS PRESSED. IN SOME INSTANCES, MULTIPLE PRESSES ARE REQUIRED TO START THE MOTOR, AND IN OTHER CASES, THE MOTOR STOPS DURING SURGERY." NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. CROSS REFERENCE MDR: 9610617-2026-00093.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24157710 ↗
• MalfunctionJan 8, 2026Mechanical Jam

  IT WAS REPORTED THAT THE MOTOR KEEPS STOPPING AND THE MESSAGE MOTOR DEFECTIVE APPEARS, FOLLOWED BY CONNECT MOTOR EVEN THOUGH THE MOTOR IS STILL CONNECTED. THE ERROR CAN BE REPRODUCED IN SHAVER BLADES MODE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007844 ↗
• MalfunctionJan 8, 2026Mechanical Jam

  IT WAS REPORTED THAT THE DEVICE MOTOR IS DEFECTED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24007841 ↗
• MalfunctionJan 7, 2026Electrical /Electronic Property Problem

  IT WAS REPORTED THAT DURING CASE SHAVER GOT STUCK AND SHOWS MOTOR DEFECTIVE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991550 ↗
• MalfunctionDec 29, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DEVICE STOPPED WORKING DURING USE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23919175 ↗
• MalfunctionDec 12, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHENEVER THEY SELECT THE SHAVER MODE ON THE UNIDRIVE AND PUSH THE FOOTSWITCH, THE HANDPIECE WORKS FOR 1 SECOND THEN IT STOPS WORKING. THE SCREEN IS TURNING ORANGE ON THE UNIDRIVE INDICATING THAT THE CONNECTION IS WORKING BETWEEN THE FOOTSWITCH AND THE UNIDRIVE BUT ONLY FOR A SECOND BEFORE TURNING BACK TO WHITE INDICATING THE CONNECTION IS SEVERED. THEY TRIED WITH ANOTHER NEW HANDPIECE AND IT WORKED IN GOOD CONDTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796395 ↗
• MalfunctionDec 12, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE HANDPIECE IS DETECTED BY THE MOTOR CONTROL UNIT BUT THE MOTOR DOESN'T MOVE OR MOVE AND STUCK AFTER FEW ROUNDS. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23796393 ↗
• MalfunctionDec 8, 2025Intermittent Energy Output; Intermittent Energy Output

  IT WAS REPORTED: "MOTOR WITH A LOUD SOUND AND SPORADIC STOPS. - E20 MOTOR STOPPED M2". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23752275 ↗
• MalfunctionNov 20, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT THE SHAVER HANDPIECE JAMMED DURING PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606876 ↗
• MalfunctionNov 13, 2025Output Problem; Output Problem; Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED: THE MOTOR DOES NOT START UNLESS THE FOOTSWITCH IS PRESSED 2-3 TIMES. THERE IS RESISTANCE, AND IT FEELS LIKE IT GETS STUCK. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23544055 ↗
• MalfunctionNov 13, 2025Output Problem; Output Problem

  THE FOLLOWING WAS REPORTED: WHEN CONNECTED TO THE UM600 AND OPERATED AT A ROTATION SPEED OF 1,500 RPM (WITH THE BLADE ATTACHED), WE OBSERVED THAT THE MOTOR OCCASIONALLY FAILED TO ROTATE OR STOPPED UNEXPECTEDLY. AT THOSE TIMES, THE EVENT LOG RECORDED 'ID 116: MOTOR IS BLOCKED. A SIMILAR PHENOMENON WAS ALSO OBSERVED WHEN THE ROTATION SPEED WAS SET TO 10,000 RPM. HOWEVER, THIS ISSUE WAS NOT OBSERVED WHEN TESTING WITH OTHER HANDPIECES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23544054 ↗
• MalfunctionNov 12, 2025Erratic or Intermittent Display; Erratic or Intermittent Display

  IT WAS REPORTED THAT THE SHAVER HAND PIECE IS GETTING STUCK OR DID NOT START AT ALL. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23533966 ↗
• MalfunctionSep 18, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT WHEN USING THE DRILLCUT-X II-35 MOTOR MAY COME TO A STANDSTILL WHEN USED IN SHAVER MODE AT SPEEDS ABOVE 8,000 RPM. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23091984 ↗