MAUDE Adverse Event Report: AESCULAP AG DERMATOME BLADES F/WAGNER DERMAT.STERILE; TOOLS FOR HIGHSPEED POWER SYST

Model Number GB228R

Device Problems Positioning Failure (1158); Defective Device (2588); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: we did receive the complained product for investigation.Failure description: besides slight signs of wear, the saw blades are in a good condition.Investigation: the saw blades have been analysed visually and microscopically.Besides slight signs of wear, the saw blades are in a good condition.Batch history review: the device history records for the available lot number has been checked and found to be according to the specification, valid at the time of production.No further complaints registered against the same lot number.Conclusion and root cause: the failure is most probably manufacturing related.Rationale: on the basis of the provided information and after the investigation, we suspect that the failure occurred during the packaging process.It is possible that two saw blades stuck together and were therefore inserted into one packaging.According to the corresponding instructions for use (ifu), the saw blades must be checked prior to use.Prior to each use, check that all products to be used are in good working order, check the secure connection of all products to be used, check that the tool is coupled properly (to do this, pull on the tool), check that the cutting edges of the tools are not showing any mechanical damage, briefly run the tool at maximum speed, do not use the product it if is damaged or defective; set aside the product if it is damaged.

Event Description

It was reported that there was an issue with a dermatome blades f/wagner dermat.Sterile.According to the description: there were two pieces of this product in the package.The doctor had set this product to the ga670 and the motion was not good.And when the doctor opened blade cover on the dermatome, there were two blades noted.In the course of skin harvesting procedure, the surgeon was unable to complete the procedure with the dermatome that did not function as expected.The surgeon stopped use of the dermatome and continued to manually harvest skin.This way, the procedure was completed, but there was obstacle.Not exactly known how long the surgical delay was.This was cause of the case.So the nature of the problem was more likely that two overlaid blades packaged in one package, rather that dermatome itself.An additional medical intervention was necessary.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).

• Brand Name: DERMATOME BLADES F/WAGNER DERMAT.STERILE
• Type of Device: TOOLS FOR HIGHSPEED POWER SYST
• 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: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9741205
• MDR Text Key: 182298665
• Report Number: 9610612-2019-00787
• Device Sequence Number: 1
• Product Code: GFD
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: GB228R
• Device Catalogue Number: GB228R
• Device Lot Number: 52398357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention