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

Model Number GA800

Device Problems Device Remains Activated (1525); Defective Device (2588)

Patient Problems Skull Fracture (2077); Brain Injury (2219)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

(b)(6).The incident was caused when drilling skull with a codman blade and ga822.Although the drilling was completed, the blade did not stop and the patient's brain was damaged.Components in use listed as concomitant devices are: ga800 / elan 4 electro control unit, ga806 / elan 4 electro motor cable f/foot ctrl., ga808 / elan 4 electro foot control, ga822 / elan 4 electro perforator driver.

• Brand Name: ELAN 4 ELECTRO CONTROL UNIT
• Type of Device: HIGH SPEED 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: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7492168
• MDR Text Key: 107566760
• Report Number: 9610612-2018-00197
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA800
• Device Catalogue Number: GA800
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/13/2018
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other