MAUDE Adverse Event Report: SIE AG, SURGICAL INSTRUMENT ENGINEERING FEMTO LDV SYSTEM; MED-PROFILE; FEMTO LDV; CLASSIC

Model Number CLASSIC

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Loss of Power (1475)

Patient Problem No Code Available (3191)

Event Date 10/19/2013

Event Type  malfunction  

Event Description

Femto ldv shut down during a surgery.The pt was sent home with a partial cut flap.The pt will come back for a re-treatment at a later date.

• Brand Name: FEMTO LDV SYSTEM; MED-PROFILE
• Type of Device: FEMTO LDV; CLASSIC
• Manufacturer (Section D): SIE AG, SURGICAL INSTRUMENT ENGINEERING; port CH-2 562; SZ CH-2562
• Manufacturer Contact: kevin walls ; 33 golden eagle lane; littleton, CO 80127 ; 7209625412
• MDR Report Key: 3745655
• MDR Text Key: 4227166
• Report Number: 3005643720-2014-00004
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 12/02/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CLASSIC
• Device Catalogue Number: 510.002.003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other