MAUDE Adverse Event Report: AESCULAP AG DERMATOME BLADES F/WAGNER DERMAT.STERILE; POWER SYSTEMS

Model Number GB228R

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.Preliminary investigation results without device evaluation: we did receive the ga670 dermatome for investigation.It has been forwarded to the aesculap technical service.This report will be updated as soon as the results are available.The mentioned dermatome blade gb228r was not provided.Optically, the dermatome is in a used but good condition.Investigation is still on going.Batch history review: the device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number (52273168).Conclusion and root cause: the failure is most probably usage / wear and tear related.Rationale: the investigation is still ongoing.This report will be updated as soon as the final results are available.However, based on the first findings, we did not receive the complained device for maintenance since the distribution.According to the labelled information, a maintenance should have took place in december 2017.Therefore, it is possible that wear and tear led to the described failure pattern.An information regarding the maintenance can also be found within the ifu " to ensure reliable operation, the product must be maintained once per year as indicated on the maintenance label [.]" (extract of ifu ta013000 - 01/14.A capa is not necessary.

Event Description

It was reported that there was an issue with product acculan dermatome blades.According to the complaint description the cutting of the dermatome was not as expected during skin sample.The skin sample was not to deep but more thin than expected.Expected: 0.4mm / real: not measurable (probably less than 0.2mm).A new blade was used, single use (as in each procedure).Location: removal of anterior face right thigh.An additional skin sample was needed.Therefore the step was performed twice.And the patient suffered temporary damage and a delay in surgery.Temporary damage that will heal fully and will most likely not negatively influence the patient in the future.Additional information was not provided.The adverse event is filed under (b)(4).Associated medwatch-reports: ((b)(4)).

Manufacturer Narrative

Investigation results after device evaluation: we did receive the ga670 dermatome for investigation.The mentioned dermatome blade gb228r was not provided.Optically, the dermatome is in a used but good condition.The dermatome was manufactured in sept 2016.No repair nor maintenance was initiated by the customer since that date.The maintenance date (2017-12) labeled on the device has expired.However there are no serious optical deviations.Minor corrosion/rust can be found.The following has been found during the functional test: the cutting sample was too thick contrary to the information received (cutting too thin): with a setting of 0,2mm a thickness of 0,3mm - 0,35mm was measured.Possible reasons for a too thin cutting: wrong/slanted approach of the dermatome.Wrong adjustment.Blunt blade.To little pressure on the skin.Possible root causes: wear and tear.Fall or impact damage.Besides the above mentioned, all other values are according to the specifications.The device history records have been checked for the available lot number and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number (52273168).The failure is most probably usage / wear and tear related.A capa is not necessary.

Event Description

The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00241 ((b)(4) + gb228r).

• Brand Name: DERMATOME BLADES F/WAGNER DERMAT.STERILE
• Type of Device: POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10201279
• MDR Text Key: 201167857
• Report Number: 9610612-2020-00241
• Device Sequence Number: 1
• Product Code: GFD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB228R
• Device Catalogue Number: GB228R
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other