Dermatome 00-8801-001-00Recalls & reported problems

Summary

The FDA's MAUDE database contains 631 adverse event reports that list this exact device (DI 00889024375901), received between Jul 2, 2019 and Sep 28, 2026 — classified as 97 injuries, 534 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (290 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Nov 24, 2025Class IIOpen, Classified

   The devices may have a misaligned thickness control bar.

   Z-0924-2026 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 631 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Calibration Problem

  It was reported that outside of surgery, a corrective repair was initiated under a recall after the device was found to cut beyond the intended depth due to a misaligned thickness control bar. There was no patient involvement. During device evaluation, it was discovered that it was missing two Phillips screws. Due diligence is complete; there is no additional information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923818 ↗
• MalfunctionSep 21, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50840778 ↗
• MalfunctionSep 1, 2026Mechanical Problem

  It was reported that a fault was found at flex during PM. During product evaluation, it was found that width plate was damaged. No patient involvement. Diligence is complete.There was no adverse event associated with this malfunction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50548002 ↗
• MalfunctionAug 26, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459174 ↗
• MalfunctionAug 25, 2026Calibration Problem

  It was reported that, outside of surgery, a device issue was identified during a recall in which the device could cut beyond the intended depth due to a misaligned thickness control bar.During device evaluation, it was discovered that the RPMs were unable to be taken due to the reciprocating arm was jumping erratically and would not settle for a reading. 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 50437085 ↗
• MalfunctionAug 25, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50435342 ↗
• MalfunctionAug 21, 2026Calibration Problem

  The device was sent in for evaluation due to a recall. There was no patient involvement. During the investigation, it was determined that the motor speeds were out of specification on the low end. Due diligence is complete.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50374762 ↗
• MalfunctionAug 17, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50283152 ↗
• MalfunctionAug 14, 2026Appropriate Device Problem Term/Code Not Available

  IIt was reported that outside of surgery the unit was sent in for preventative maintenance and later discovered to need repair. Investigation results found device had inconsistent speed. There was no patient involvement. Due diligence is complete.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50252680 ↗
• MalfunctionAug 12, 2026Appropriate Device Problem Term/Code Not Available

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50229835 ↗
• MalfunctionJul 31, 2026Mechanical Problem

  It was reported that during kit inspection, the device's burns theatre handpiece not working, the device needed a new blades and new tin. After final assessment, inconsistent speed was confirmed. There was no note of patient impact or delay. Due diligence is completed and there is no additional information available.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50099239 ↗
• MalfunctionApr 27, 2026Failure to Cut

  There is no additional information available regarding the event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25008068 ↗
• MalfunctionApr 27, 2026Failure to Cut

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE UNIT WAS NOT CUTTING CORRECTLY, THERE WAS NO PATIENT INVOLVEMENT. DUE DIIGENCE IS IN PROGRESS AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24998536 ↗
• MalfunctionApr 22, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME IN JANUARY 2025, THE DEVICE WAS IN NEED OF REPAIR FOR AN UNKNOWN REASON. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE 4 IN. AND 1 IN. WIDTH PLATES WERE DAMAGED. THERE WAS NO PATIENT HARM/INJURY REPORTED. DUE DILIGENCE IS COMPLETE; NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954791 ↗
• MalfunctionApr 20, 2026Incorrect Measurement

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME THE DEPTH SETTING IS NOT ACCURATE. GAUGE READ 12 BUT STILL TOOK A FULL THICKNESS GRAFT. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT AND DILIGENCE IS COMPLETE.

  Patient problems: Insufficient Information

  MAUDE report 24925317 ↗
• MalfunctionApr 20, 2026Failure to Cut

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE WAS NOT CUTTING PROPERLY. IT IS UNKNOWN IF THERE WAS ANY PATIENT IMPACT OR SURGICAL DELAY. DILIGENCE IS COMPLETE AS NO ADDITIONAL INFORMATION WAS NOTED.

  Patient problems: Insufficient Information

  MAUDE report 24925298 ↗
• MalfunctionApr 15, 2026Mechanical Problem

  IT WAS REPORTED THAT THE UNIT WAS SENT IN FOR PREVENTIVE MAINTENANCE ONLY AND FOUND TO HAVE A FAULT. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE MOTOR WAS SEIZED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889451 ↗
• MalfunctionApr 7, 2026Incorrect Measurement

  IT WAS REPORTED THAT THE DEVICE CUT A DEEPER DEPTH THAN WHAT IT WAS SET FOR. NO PATIENT HARM OR SURGICAL DELAY WAS NOTED. NO ADDITIONAL INFORMATION WAS NOTED AS A RESULT DILIGENCE IS COMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800673 ↗
• MalfunctionApr 6, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN UNKNOWN TIME, THE DEVICE HAD AN UNKNOWN DEFICIENCY. IT IS UNKNOWN IF THERE WAS PATIENT IMPACT OR DELAY. DURING PRODUCT EVALUATION IT WAS FOUND THAT THE DEVICE WAS LEAKING AIR. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24794968 ↗
• MalfunctionApr 6, 2026Failure to Power Up

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE UNIT WAS FOUND TO HAVE A SEIZED MOTOR. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE UNIT WAS FOUND TO HAVE A SEIZED MOTOR. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793754 ↗
• MalfunctionApr 6, 2026Failure to Power Up

  IT WAS REPORTED THAT OUTSIDE OF SURGERY, THE UNIT DID NOT TURN ON. THERE WAS NO PATIENT INVOLVEMENT. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE UNIT WAS FOUND TO HAVE A SEIZED MOTOR. DURING DEVICE EVALUATION IT WAS DISCOVERED THAT THE UNIT WAS FOUND TO HAVE A SEIZED MOTOR. DUE DILIGENCE IS COMPLETE, THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793753 ↗
• MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY THE DEVICE WAS SENT FOR CORRECTIVE REPAIR. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION IT WAS FOUND THAT THERE WERE MISSING SCREWS. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24747834 ↗
• MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT OUTSIDE OF SURGERY ON AN UNKNOWN DATE, THE DEVICE WAS SENT TO PREVENTIVE MAINTENANCE. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS THERE WAS NO PATIENT INVOLVEMENT. AFTER INVESTIGATION INCONSISTENT SPEED WAS FOUND. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24744934 ↗
• MalfunctionMar 31, 2026Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE DEVICE WAS SENT IN FOR PREVENTIVE MAINTENANCE. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE MOTOR SPEEDS WERE OUT OF SPECIFICATION ON THE LOW END. THERE WAS NO PATIENT HARM/INJURY OR SURGICAL DELAY AS 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 24741812 ↗
• MalfunctionMar 26, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE, THE DEVICE WAS SENT IN FOR ANNUAL SERVICE AND CALIBRATION BUT IT WAS FOUND THAT THE DEVICE HAD AN UNKNOWN FAULT. THERE WAS NO PATIENT INVOLVEMENT. DURING PRODUCT EVALUATION, IT WAS FOUND THAT THE WIDTH PLATE WAS DAMAGED. DUE DILIGENCE IS COMPLETE AND THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701899 ↗