ACCULAN 3TI GA670Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04046963406196), received between Jan 3, 2022 and Feb 17, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Dull, Blunt” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 17, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO AESCULAP AG THAT AN ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE WAS USED TO CUT A GRAFT. REPORTEDLY, THE GRAFT WAS COMPLETE, BUT UNEVEN; THE THICKNESS OF THE GRAFT WAS VARYING, WHICH WAS ABNORMAL. AN ADDITIONAL GRAFT NEEDED TO BE TAKEN TO CONTINUE AND COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13550412 ↗
• InjuryFeb 11, 2022Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED TO AESCULAP (B)(4) THAT AN ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SKIN GRAFT SPLIT. REPORTEDLY, THE OPERATING ROOM (OR) STAFF HARVESTED THE GRAFT USING ONLY THE DERMATOME, WITH THE SURGEON PRESENT. NO MESHER WAS USED AND NO INSPECTION OF THE DERMATOME WAS PERFORMED BY THE SURGEON AFTER THE GRAFT. A SECOND GRAFT HAD TO BE TAKEN ON THE OPPOSITE LEG AS A RESULT OF THE ISSUE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AESCULAP (B)(4) REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514994 ↗
• InjuryFeb 9, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED TO AESCULAP AG THAT AN ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE DERMATOME CAUSED THE SKIN GRAFT TO BE TORN. A SECOND GRAFT WAS REQUIRED TO COMPLETE THE SURGERY. THE SECOND GRAFT WAS TAKEN FROM THE PATIENT'S OTHER LEG INSTEAD. THE COMPLAINT DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. A SECOND GRAFT WAS REQUIRED TO COMPLETE THE SURGERY. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499347 ↗
• InjuryFeb 9, 2022Dull, Blunt; Dull, Blunt

  IT WAS REPORTED TO AESCULAP AG THAT AN ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE DERMATOME CAUSED THE SKIN GRAFT TO BE TORN. A SECOND GRAFT WAS REQUIRED TO COMPLETE THE SURGERY. THE SECOND GRAFT WAS TAKEN FROM THE PATIENT'S OTHER LEG INSTEAD. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. ADDITIONAL PATIENT INFORMATION IS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499291 ↗
• InjuryFeb 9, 2022Failure to Cut; Failure to Cut

  IT WAS REPORTED TO AESCULAP AG THAT AN ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO CUT OUT A GRAFT TWO TIMES, BUT BOTH TIMES THE GRAFT WAS SPLIT IN THE MIDDLE. AN ADDITIONAL GRAFT NEEDED TO BE TAKEN TO CONTINUE AND COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THEY USED THE DEVICE AGAIN, THIS TIME THE GRAFT WAS COMPLETE BUT UNEVEN - THE THICKNESS OF THE GRAFT WAS VARYING WHICH IS ABNORMAL. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13498811 ↗
• InjuryJan 3, 2022Degraded; Degraded

  IT WAS REPORTED TO AESCULAP AG THAT A ACCULAN 3TI DERMATOME (PART # GA670) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SKIN COLLECTION FUNCTION FAILED. THIS PRODUCT DID NOT COLLECT SKIN WELL, AND THE PATIENT'S SKIN WAS CUT INTRICATELY. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THERE WAS PERMANENT IMPAIRMENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Scar Tissue

  MAUDE report 13142138 ↗