Dermatome 00-8821-001-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 614 adverse event reports that list this exact device (DI 00889024375994), received between Oct 25, 2019 and Sep 30, 2026 — classified as 18 injuries, 596 malfunctions.

The most frequently reported specific device problem is “Unstable” (112 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 25 most recent of 614 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Corroded; Material Deformation; Naturally Worn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50950525 ↗
• MalfunctionSep 18, 2026Corroded; Device Contamination with Chemical or Other Material; Material Deformation; Naturally Worn

  It was reported that outside of surgery, the unit had a corroded motor, contaminated insulation and damaged part like plug harness assembly, worn screws and worn reciprocation arm. Inconsistent speed was confirmed after final investigation. There was no patient involvement. Due diligence is complete as no further information is available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820425 ↗
• MalfunctionAug 18, 2026Key or Button Unresponsive/not Working

  Patient problems: Insufficient Information

  MAUDE report 50298989 ↗
• MalfunctionApr 28, 2026Corroded; Naturally Worn

  IT WAS REPORTED THAT DURING MAINTENANCE, THE DEVICE HAD A CORRODED MOTOR, WORN RECIPROCATION ARM, AND WORN SCREWS. INVESTIGATION RESULTS INDICATE THAT THE MOTOR SPEEDS WERE UNSTABLE. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25018186 ↗
• MalfunctionApr 23, 2026Mechanical Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE IS NOT WORKING. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE MOTOR SPEEDS WERE NOT STABLE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971669 ↗
• MalfunctionApr 21, 2026Mechanical Problem

  IT WAS REPORTED AN UNKNOWN TIME; THE DEVICE WAS OUT OF ORDER. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEEDS WERE UNSTABLE. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETED; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 24939389 ↗
• MalfunctionApr 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE THE DEVICE WAS FOUND TO HAVE A FAULT. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEEDS WERE UNSTABLE AND THE WIDTH PLATES WERE DAMAGED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900000 ↗
• MalfunctionApr 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME A REPAIR QUOTE WAS REQUESTED. NO INFO PROVIDED ON HARM OR DELAY. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE MOTOR SPEEDS WERE UNSTABLE. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24899887 ↗
• MalfunctionApr 9, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE CUSTOMER REQUESTED PREVENTATIVE MAINTENANCE FOR THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, THE MOTOR SPEEDS WERE NOT STABLE. DUE DILIGENCE IS COMPLETE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24828797 ↗
• MalfunctionApr 2, 2026Calibration Problem; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT WAS IN NEED OF ANNUAL CALIBRATION AND MAINTENANCE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEED WAS LOW. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769294 ↗
• MalfunctionMar 30, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE WAS SENT IN FOR PREVENTATIVE MAINTENANCE ORIGINALLY AND FOUND TO BE NEEDING REPAIRED. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEEDS WERE ERRATIC. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714787 ↗
• MalfunctionMar 30, 2026Unstable

  IT WAS REPORTED THAT DURING SURGERY, THE UNIT WAS SKIPPING SECTIONS. IT WAS UNKNOWN IF THERE WAS PATIENT HARM OR SURGICAL DELAY. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24714201 ↗
• MalfunctionMar 19, 2026Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE WAS NOT WORKING OUTSIDE OF SURGERY. SERVICE EVALUATION IDENTIFIED THE DEVICE HAD UNSTABLE MOTOR SPEED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637685 ↗
• MalfunctionFeb 24, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE THERE WAS A FAULT FOUND. THERE WAS NO PATIENT INVOLVEMENT. DURING THE INVESTIGATION IT WAS FOUND THE DEVICE HAD INCONSISTENT SPEED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24428353 ↗
• MalfunctionJan 28, 2026Corroded; Calibration Problem; Material Deformation

  IT WAS REPORTED THAT DURING MAINTENANCE INSPECTION, DEVICE HAD A CORRODED MOTOR, CALIBRATION ERROR, AND DAMAGED DERMATOME CABLE. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION, IT WAS DISCOVERED THAT THE MOTOR SPEED WAS UNSTABLE. DUE DILIGENCE INFORMATION COMPLETE, THERE WAS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24200877 ↗
• MalfunctionJan 26, 2026Break

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE UNIT WAS SENT TO PREVENTIVE MAINTENANCE, AND WAS ALSO INFORMED THAT IT WAS BROKEN. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY REPORTED. DURING THE INVESTIGATION, INCONSISTENT SPEED WAS FOUND ON THE DEVICE. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179348 ↗
• MalfunctionJan 26, 2026Intermittent Loss of Power

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEPARTMENT REPORTS THAT THIS DERMATOME STARTED UP BUT STOPPED AFTER A FEW SECONDS. NO INFO ON HARM OR DELAY WAS PROVIDED. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 24179178 ↗
• MalfunctionJan 22, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING KIT INSPECTION THE UNIT WAS NONFUNCTIONAL. INCONSISTENT SPEED WAS CONFIRMED AFTER FINAL ASSESSMENT. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24149330 ↗
• MalfunctionJan 14, 2026Material Frayed

  IT WAS REPORTED THAT AFTER SURGERY DURING CLEANING THE DEVICE HAD A BARE WIRE, STRIPPED/DAMAGED PAM CABLE. THE METAL WIRES WERE EXPOSED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AS MULTIPLE ATTEMPTS WERE MADE; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE. AS NO ADDITIONAL INFORMATION IS AVAILABLE, WE ARE UNABLE TO PROVIDE FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068488 ↗
• MalfunctionDec 30, 2025Output below Specifications; Complete Loss of Power; Activation Problem; Output below Specifications; Complete Loss of Power; Activation Problem

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE DID NOT STAY ON, HAD A LOWER-THAN-EXPECTED MOTOR SPEED, AND THE CUTTING WAS NOT ACTIVATING. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 20 MINUTE DELAY WITH NO PATIENT IMPACT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23926613 ↗
• MalfunctionDec 15, 2025Unexpected Shutdown; Unexpected Shutdown

  IT WAS REPORTED THAT DURING SURGERY, THE DERMATOME SUDDENLY STOPPED WORKING AND COULD NOT BE RESTARTED. THERE IS NO INFORMATION PROVIDED REGARDING PATIENT HARM OR SURGICAL DELAY. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23804526 ↗
• MalfunctionDec 15, 2025Material Frayed; Material Frayed

  IT WAS REPORTED AN UNKNOWN TIME, ON AN UNKNOWN DATE, THE DEVICE HAD A BARE WIRE. THERE WAS NO NOTE OF PATIENT IMPACT OR DELAY. DUE DILIGENCE IS COMPLETED; NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 23803429 ↗
• MalfunctionDec 2, 2025Intermittent Loss of Power; Intermittent Loss of Power

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT HAS A FAULTY LEVER/SAFETY SWITCH. IT POWERS UP BUT INTERMITTENTLY LOSES POWER WHILE THE POWER BUTTON IS PRESSED, AND THE ISSUE CONTINUES EVEN AFTER THE BUTTON IS RELEASED. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695594 ↗
• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNITS DID NOT WORK. INCONSISTENT SPEED WAS CONFIRMED AFTER FINAL INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657734 ↗
• MalfunctionNov 26, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNITS DID NOT WORK. INCONSISTENT SPEED WAS CONFIRMED AFTER FINAL INVESTIGATION. THERE WAS NO PATIENT INVOLVEMENT. DUE DILIGENCE IS COMPLETE; THERE IS NO ADDITIONAL INFORMATION AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657723 ↗