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

Model Number	GA800
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
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 to aesculap that a elan 4 electro control unit (part # ga800) was to be used during a laminectomy procedure performed on (b)(6) 2021.According to the complainant, the device did not work correctly.Reportedly, when the control unit was plugged in, it began its normal startup procedure.However, when the hand-control cord was plugged into the unit, the display flashed red, then black, and returned to the startup procedure.The unit was reset, but the error recurred.Additionally, due to the rural location of the facility, another control unit was not immediately available, which resulted in the cancellation of the case.The complaint device was returned to the manufacturer for evaluation.Additional information has been requested, but has not yet been received.The malfunction is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• 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: 11387904
• Report Number: 9610612-2021-00126
• Device Sequence Number: 3866008
• Product Code: HBC
• UDI-Device Identifier: 04046963794255
• UDI-Public: 4046963794255
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 06/02/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1