MAUDE Adverse Event Report: AESCULAP AG ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS

Model Number GA804

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2018

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.Manufacturing site evaluation: evaluation on-going.Date reportability change due to re-assessment.Similar device elan 4 electric motor system: k152960.Pending further information.

Event Description

It was reported by the healthcare professional to the company sales representative "the lever was not released, not back to the normal position during use.The product was newly purchased and a test was performed the day before surgery, and confirmed it worked properly.The first day used, the product worked without problems for the first surgery, however, in the second surgery, the lever would not release.The sales rep checked the product after the surgery and confirmed the lever was not releasing smoothly or never released.By checking the motion of the lever repeatedly, the failure was getting better but still not properly releasing.The surgical procedure was completed by using another device.There was no harm to the patient reported.This incident did not cause any delay in surgery.

Manufacturer Narrative

We did receive the product in decontaminated condition for investigation.Optically, the motor cable is in good condition.The motor cable has been checked visually.A functionally test by r&d revealed no deviation.The lever operates as intended.On the headpiece connection side, staining could be detected on several locations.In the course of the investigation, it could be detected that the thread of the sleeve can be seen.This is only an optical flaw which does not stand in correlation with the lever issue.The device history records have been checked and found to be according to the specification, valid at the time of production.No further compliant register against the same lot number.The failure is usage related.On the basis of the provided information as well as the internal investigation, the bone wax came in contact with the lever during the surgery.This led to the mentioned failure pattern.No product related failure.There is no capa necessary.

• Brand Name: ELAN 4 ELECTRO MOTOR CABLE W/HAND SWITCHHIGH SPEED POWER SYSTEMS
• Type of Device: HIGH SPEED POWER SYSTEMS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 8039519
• MDR Text Key: 126512488
• Report Number: 9610612-2018-00484
• Device Sequence Number: 1
• Product Code: HBC
• Combination Product (y/n): N
• PMA/PMN Number: SEE H.10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA804
• Device Catalogue Number: GA804
• Device Lot Number: 52422024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Distributor Facility Aware Date: 12/06/2018
• Device Age: 2 MO
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1