MAUDE Adverse Event Report: AESCULAP AG MICROSPEED UNI CONTROL UNIT W/COOL.UNIT; HIGHSPEED POWER SYSTEMS

Model Number GD670

Device Problem Complete Loss of Power (4015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/02/2021

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 gd670 - microspeed uni control unit w/cool.Unit.According to the complaint description, the device stopped working during surgery.This event/malfunction prolonged the surgery.It had stopped rotating, and another device was used.Additional information was not provided nor available.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).

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.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.Based upon the investigations results, a capa is not necessary.

• Brand Name: MICROSPEED UNI CONTROL UNIT W/COOL.UNIT
• Type of Device: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11716860
• MDR Text Key: 266753996
• Report Number: 9610612-2021-00335
• Device Sequence Number: 1
• Product Code: GEA
• 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: 05/21/2021

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
• Device Operator: Health Professional
• Device Model Number: GD670
• Device Catalogue Number: GD670
• Device Lot Number: 52262720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/23/2021
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1