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

Model Number	GD675
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with gd675 - microspeed uni xs highspeed motor.According to the complaint description, the unit display showed an error after a function check when the pedal was pressed.This could not be rectified even after several restarts.The planned operation was carried out with a replacement unit.There was no described patient harm.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.According to the corresponding ifu, a maintenance must take place at least once per year.Based upon the investigations results a capa is not necessary.
Event or Problem Description
New information: at 9:00 am on (b)(6) 2021, checked microspeed motor system of bbraun before orthopedic surgery and found that the power on screen of the equipment was normal.Connected the high-speed motor lead line gd675.When the device pedal was down, error 9 appeared on the host screen, and gd675 high-speed motor did not rotate.Plugged in the interface, restarted the device system several times, the fault had not been eliminated.As the patient had entered the operating room to start anesthesia, the equipment was stopped after asking for instructions.Replaced spare equipment and provided it to doctors for operation.No harm had been done to the patient.No sample or picture provided.

• 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: 11553121
• Report Number: 9610612-2021-00199
• Device Sequence Number: 17104823
• Product Code: HBC
• UDI-Device Identifier: 04038653347605
• UDI-Public: 4038653347605
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K053526
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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: 52323329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR