MAUDE Adverse Event Report: AESCULAP AG MICROSPEED UNI XS HIGHSPEED MOTOR; HIGHSPEED POWER SYSTEMS

Model Number	GD675
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: the device was received in a used condition.The investigation has been carried-out by the aesculap technical service (ats).The motor gd675 with the serial number (b)(4) was manufactured in april 2014.Two repairs / maintenances can be found in the our database (july 04, 2017 and august 16, 2018).The laser engraving shows that the next maintenance should have taken place in july 2019.The motor was checked and no failure could be detected.The device was checked according to the internal test instruction.All values are according to the specification.Temperature before running: 23,6 degree.Temperature after a running time of three minutes: 30,2 degree.Allowed heating: max.14 degree.Afterwards, the motor was checked under excessive overload for two minutes which resulted in a temperature of 73 degree.Therefore, we assume that the heating occurred due to an overload situation.Furthermore the maintenance date is overdue.Relevant safety hints can be found within the ifu.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 similar complaints registered against the same lot number.The failure is most probably usage related.
Event or Problem Description
It was reported that there was an issue with the product microspeed uni xs highspeed motor.As per received information the drill is overheating and burned the user's hand; reportedly, the burn was superficial.Additional information was requested but is not yet available.The malfunction is filed under aag reference (b)(4).

• Brand Name: MICROSPEED UNI XS HIGHSPEED MOTOR
• Common Device Name: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9418926
• Report Number: 9610612-2019-00806
• Device Sequence Number: 2450980
• Product Code: HBC
• UDI-Device Identifier: 04038653347605
• UDI-Public: 4038653347605
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K053526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GD675
• Device Catalogue Number: GD675
• Device Lot Number: 52018932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2019
• Initial Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1