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

Model Number GA670

Device Problem Dull, Blunt (2407)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/28/2021

Event Type  Injury  

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

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).

Manufacturer Narrative

Investigation results: the investigation was carried out by the aesculap technical services (ats) and took place according to internal specifications.The device was manufactured and delivered in (b)(6) 2012.The investigation results showed that the product passed all inspection points.The next maintenance due date according to the laser marking is (b)(6) 2022.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale: there was no error detected with the device.Conclusion and measures / preventive measures: due to the current deviation and according to the explanation above, the root cause of the problem is most probably usage-related.Based upon the investigations results 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: 13499347
• MDR Text Key: 285354520
• Report Number: 9610612-2022-00011
• Device Sequence Number: 1
• Product Code: GFD
• UDI-Device Identifier: 04046963406196
• UDI-Public: 4046963406196
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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: 51832536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2012
• 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): Required Intervention