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

Model Number GA670

Device Problem Degraded (1153)

Patient Problem Scar Tissue (2060)

Event Date 12/08/2021

Event Type  Injury  

Event Description

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).

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

Update: the patient scarred; there was no infection.

Manufacturer Narrative

Investigation results:: the investigation was carried-out by the aesculap technical service (ats).The complete analysis results can be found within pc notification.The device with the serial number (b)(6) was manufactured in july 2011 and delivered to japan in august 2011.A repair took place in october 2020.According to the labeling on the device, a maintenance would have been necessary in october 2021.Extract of the ats analysis: visual inspection - marking and surface - passed.Function control - all passed.Detailed analysis after disassembly - corrosion and residues - none.Inspection at component level - pate with friction marks; rocker arm had slight indentation on the pivot of the rocker arm.Conclusion - cutting test ok.Running noise with blade in place.Friction marks on the plate.Adjusting shaft scratches slightly.The complained failure pattern could not be confirmed, as the cutting test did not show any deviation.The findings are most likely wear and tear related.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 2(5)) according to din en iso 14971 is still acceptable.Explanation and rationale /conclusion and root cause: due to the current deviation and according to information above, the root cause of the problem is most probably wear and tear and lack of maintenance.A capa is not necessary.

• Brand Name: ACCULAN 3TI DERMATOME
• Type of Device: 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: 13142138
• MDR Text Key: 283090060
• Report Number: 9610612-2021-00791
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 04046963406196
• UDI-Public: 4046963406196
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA670
• Device Catalogue Number: GA670
• Device Lot Number: 51767458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability