MAUDE Adverse Event Report: LEICA MICROSYSTEMS SCHWEIZ AG LEICA M520 MS2; MICROSCOPE, SURGICAL

Model Number M520 MS2

Device Problem Insufficient Information (3190)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 12/23/2013

Event Type  Injury  

Event Description

On (b)(6) 2013, leica microsystems received a complaint stating that during a dermatological surgical procedure using the leica m520 ms2 surgical microscope, the pt received a second degree burn on the skin.

Manufacturer Narrative

Affected device is in eval.If add'l info becomes available, a f/u report will be submitted to the fda.

• Brand Name: LEICA M520 MS2
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS SCHWEIZ AG; max schmidheinystrasse 201; heerbrugg 9435 ; SZ 9435
• Manufacturer Contact: max schmidheinystrasse 201; heerbrugg CH-94-35
• MDR Report Key: 3591164
• MDR Text Key: 4035012
• Report Number: 3003974370-2014-00001
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M520 MS2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR