MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE WAGNER DERMATOME; POWER SYSTEMS

Model Number GB231R

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing side evaluation we did receive a complaint about a gb231r - micro-line wagner dermatome regarding an intraoperative issue.We did receive the product in a decontaminated condition for investigation.Therefore, the dermatome has been forwarded to the aesculap technical service.After the investigation has been executed, this report will be updated.Temporary damage that will heal fully and will most likely not negatively influence the patient in the future.Investigation: optically, the device is in a used but good condition.Investigation 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 (51382626).Conclusion and root cause: on the basis of the current knowledge, we exclude a product related failure.It is possible that a usage related failure led to the described failure pattern.However, the investigation is still ongoing.Therefore, this report will be updated after the results are available.Corrective action: a capa is not necessary according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action).

Event Description

It was reported that there was an issue with micro-line wagner dermatome.The gap does not open properly to feed through the skin.The only time the gap opens is on lever 5 which is not used as it is too big.It is possible that the patient suffers an temporary impairment as a result.Additional information was not provided nor available.The adverse event/malfunction is filed under (b)(4).

Manufacturer Narrative

Failure description: optically, the device is in a used but good condition.Investigation: the investigation has been carried out by the aesculap technical service (ats).History: the complained gb231r, serial number (b)(6) is a rental device coming from b.Braun medical, sheffield.The dermatome was manufactured and delivered in february 2007.One complaint can be found in the database against the same dermatome from may 2019.The reason for the complaint was a potential overheating, therefore it was shipped to the ats tuttlingen.After the analysis, a cost estimate for a repair was created but declined by sheffield, hence the dermatome was shipped back unrepaired free of charge.Repairs/check-ups were executed by sheffield afterwards (may, july and december 2019).Failure analysis: during a functional check an insufficient cutting on the test material could be detected, due to a too small cutting cap which was adjusted by an external ats.Furthermore, eccentric bushes on the clamping levers are responsible for a correct adjusting of the clamping force of the upper plate.These bushes were not adjusted sufficiently.Therefore, the following occurred: - it was not possible to fixate the plate.- the clamping levers could open unintentionally.- the cutting gap was one-sided.- the plate could open unintentionally and release the blade.Pictures, see figure 3 and 4.Additionally, after opening the upper plate, residues of unknown origin could be detected.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 (51382626).Conclusion and root cause: the failure is most probably repair related.Rationale: on the basis of the market surveillance and statistical analysis, this is evaluated as an individual case.No signs for a systematic failure.Corrective action: a capa is not necessary according to sop sa-de13-m-4-2-04-000-0 (corrective action and preventive action).

• Brand Name: MICRO-LINE WAGNER DERMATOME
• Type of Device: POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9528471
• MDR Text Key: 179470049
• Report Number: 9610612-2019-00860
• 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: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB231R
• Device Catalogue Number: GB231R
• Device Lot Number: 51382626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1