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

Model Number	GD670
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
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 gd670 - microspeed uni control unit w/cool.Unit.According to the complaint description, the patient was operated under general anesthesia.During skull milling, it was found that the outer end cover of the milling cutter handle bearing fell off, and the bearing inside the handle (gb740r) was out of position and could not be used.Replaced other handles immediately, and contacted equipment department for maintenance.It may cause permanent damage to the functional structure of the body.No sample or picture provided.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
B5: updated 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.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.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.Furthermore, consumables during use was not original, the products were maintained/repaired by a third party.According to the ifu, such devices should only be maintained/repaired by aesculap.Based upon the investigations results a capa is not necessary.
Event or Problem Description
It was known this hospital outsourced device maintenance to a third party service provider.Maintenance status of the device was unknown.Furthermore, consumables during use was not original.As this complaint was not informed to our engineer, condition of its use and maintenance was not assessable.
Event or Problem Description
Update: information was received which confirmed that there had been no patient harm.
Additional Manufacturer Narrative
Additional information/correction: b5 - patient harm updated to "none".After receipt of additional information and clarification that there had been no patient harm, the complaint was re-assessed and determined to no longer be reportable (no malfunction nor serious injury).
Additional Manufacturer Narrative
Additional information/correction: b5 - patient harm updated to "none" after receipt of additional information and clarification that there had been no patient harm, the complaint was re-assessed and determined to no longer be reportable (no malfunction nor serious injury).
Event or Problem Description
Update: information was received which confirmed that there had been no patient harm.

• Brand Name: MICROSPEED UNI CONTROL UNIT W/COOL.UNIT
• Common Device Name: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der gruen ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10924576
• Report Number: 9610612-2020-00839
• Device Sequence Number: 20916061
• Product Code: HBC
• UDI-Device Identifier: 04038653347551
• UDI-Public: 4038653347551
• 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: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GD670
• Device Catalogue Number: GD670
• Device Lot Number: 51818930
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/09/2020; 05/04/2023; 05/04/2023
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 12/28/2020; 05/14/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown