MAUDE Adverse Event Report: AESCULAP AG MICROSPEED UNI CONTROL UNIT W/COOL.UNIT; MOTOR, DRILL, ELECTRIC

Model Number	GD670
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/12/2021
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 to aesculap ag that a microspeed uni power control unit (part # gd670) was used during an intracranial aneurysm clipping under general anesthesia performed on (b)(6) 2021.According to the complainant, while attempting to perform the craniotomy, the power handle had no output, and then the main engine alarmed.Additional handles were used, but experienced the same issue and system fault.The motor was replaced, and then the procedure was able to be continued normally.The complaint device was not available to be returned to the manufacturer for evaluation.A permanent impairment was reported, however, no further details were provided.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Investigation results no product received.Without a product and due to the lack of information no investigation is possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based on the provided information and without a product for investigation, a clear conclusion cannot be drawn.Furthermore a review of the device history records must remain incomplete due to missing information.Based upon the investigations results there is capa is not necessary.
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: MOTOR, DRILL, ELECTRIC
• 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: 11308870
• Report Number: 9610612-2021-00071
• Device Sequence Number: 1165281
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 02/11/2021; 05/04/2023
• Initial Report FDA Received Date: 02/10/2021
• Supplement Report FDA Received Date: 03/09/2021; 05/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2013
• 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: Disability
• Patient Age: 69 YR
• Patient Sex: Female