MAUDE Adverse Event Report: AESCULAP AG MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT; HIGHSPEED POWER SYSTEMS

Model Number GB109

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with a micro-line hand piece.Patient got injured (burned) inside of the mouth during an cmf intervention.Possibly by an overheated handpiece or micromotor.There was a minor, temporary impairment for the patient.Additional information was not provided nor available.The malfunction is filed under aag reference (b)(4).The following devices were sent in additionally but were not causative for this case / involved components: gd679 - microspeed uni micro 100 motor - 51316798.Gd672 - microspeed uni motor cable f/foot ctrl.- 51324283.

Manufacturer Narrative

The following devices were sent in additionally but were not not causative for this case / involved components: gd679 - microspeed uni micro 100 motor - 51316798 gd672 - microspeed uni motor cable f/foot ctrl.- 51324283 evaluation: all three devices are optically in a good but used condition.Investigation - the investigation of the three devices has been carried-out by the aesculap technical service (ats).Gb109 - micro-line straight hdpc 1:1 round shaft a manufacturing- or a delivery date is not detectable.The first repair took place in (b)(6) 2008.The last repair was executed in may 2019 with the following result regarding the failure pattern: interior soiled and corrosion.Optically, the present handpiece is in a good condition.Slight but uncritical running noises can be detected.A heating of the handpiece is not detectable (max: 29,5 degrees).After the disassembly, the interior showed slight impurities (abrasion).Besides the slight running noises, the handpiece is according to specification.Gd679 - microspeed uni micro 100 motor the device has been manufactured in (b)(6) 2006 and the last repair took place in march 2018.The laser marked maintenance due date shows "2019-03".A functional test did not reveal any deviations.A heating can not be detected.Gd672 - microspeed uni motor cable f/foot ctrl.The device has been delivered in (b)(6) 2006 and the last repair/maintenance took place in (b)(6) 2018.The plug and the coupling are discolored due to age.The cable itself does not show any damages.A functional check reveals a strong heating approx.60cm from the connection side (generator) after a few seconds (25-30 seconds, 60 degrees), which is a clear hint of an interruption due to wear and tear.Additionally, a maintenance should have been executed in (b)(6) 2019 according to the laser marking on the product "2019-05".Batch history review - the device history records have been checked for the available lot numbers mentioned above and found to be according to the specification, valid at the time of production.No further similar complaints are registered against these lot numbers.Conclusion and root cause - the failure is most probably maintenance / wear and tear related.Rationale - after the investigation of the three devices, a heating can be detected at the gd672 motor cable.It is most probably that the missing maintenance (due date 2019-05) in combination with wear and tear led to the described failure.An extract of the associated instructions for use (ifu) can be found under point 8.2.The handpiece gb109 as well as the micro motor gd679 did not show any deviations in form of heating.There can be no causality between the heating of the motor cable and the reported burning inside of the patients mouth.Corrective action - according to sop sa-de13-m-4-2-04-000-0 (corrective action & preventive action) a capa is not necessary.

• Brand Name: MICRO-LINE STRAIGHT HDPC 1:1 ROUND SHAFT
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8950563
• MDR Text Key: 156656163
• Report Number: 9610612-2019-00601
• Device Sequence Number: 1
• Product Code: HWE
• 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: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GB109
• Device Catalogue Number: GB109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2019
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GD672 - 51324283; GD679 - 51316798