MAUDE Adverse Event Report: AESCULAP AG ACCULAN 3TI DERMATOME; POWER SYSTEMS

Model Number	GA670
Medical Device Problem Code	Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
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).
Additional Manufacturer Narrative
Investigation results: visual investigation: the investigation has been carried-out by the aesculap technical service (ats) and took place according to internal specifications.The device was manufactured in april 2013 and distributed in may 2013.The next maintenance due date according to the laser marking would have been (b)(6) 2022.The visual and functional inspection was without any deviations.The only deviation which was found were untypical running noises when the blade is inserted.Swing-lever was worn-out.This may have led to the described failure.Based on the provided information and after the investigation, the failure is most probably repair/service related.It seems that the driver, which is related to the correct functioning of the swing levers, has not been inserted correctly during the last service.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of risk assessment revealed that the overall risk level (severity 2(5) x probability of occurrence 3(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.

• Brand Name: ACCULAN 3TI DERMATOME
• Common Device Name: POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 13514994
• Report Number: 9610612-2022-00046
• Device Sequence Number: 14571223
• Product Code: GFD
• UDI-Device Identifier: 04046963406196
• UDI-Public: 4046963406196
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GA670
• Device Catalogue Number: GA670
• Device Lot Number: 51929729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 02/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown