MAUDE Adverse Event Report: AESCULAP AG ELAN 4 ELECTRO CONTROL UNIT; HIGHSPEED POWER SYSTEMS

Model Number	GA800
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 ga800 - elan 4 electro control unit.According to the complaint description, the device turned off and restarted automatically during surgery.This malfunction caused a surgery delay.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Manufacturer evaluation: the elan 4 electro control unit was returned to the manufacturer for evaluation.Machine functional checks were performed.No system issues were identified.Functional testing was performed which confirmed that the unit was operating properly.No device malfunction was observed or identified during the evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process which could be associated with the reported event.In addition, the device history record (dhr) review confirmed the labeling, material, and process controls were within specification.The investigation into the cause of the reported event was not able to confirm a device issue which would have resulted in the malfunction.
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.No failure detected during investigation.Product functions as intended.No reporting obligation.

• Brand Name: ELAN 4 ELECTRO CONTROL UNIT
• Common Device Name: HIGHSPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11553244
• Report Number: 9610612-2021-00224
• Device Sequence Number: 17104824
• Product Code: HBC
• UDI-Device Identifier: 04046963794255
• UDI-Public: 4046963794255
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K152960
• 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,Followup
• Report Date (Section B): 05/12/2021

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: GA800
• Device Catalogue Number: GA800
• Device Lot Number: 52383050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/17/2021; 04/20/2021
• Initial Report FDA Received Date: 03/23/2021
• Supplement Report FDA Received Date: 04/16/2021; 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1