MAUDE Adverse Event Report: LEICA MICROSYSTEMS SCHWEIZ AG LEICA M525 F50; MICROSCOPE, SURGICAL

Model Number M525 F50

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/26/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, leica microsystems received a complaint stating that during a surgical procedure, the illumination of the leica m525 rf50 surgical microscope did not work.The surgical procedure was completed by using another microscope.

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted; should additional information become available, following the investigation.

• Brand Name: LEICA M525 F50
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS SCHWEIZ AG; max schmidheinystrasse 201; heerbrugg 9435 ; CH 9435
• Manufacturer Contact: roland jehle ; max schmidheinystrasse 201; heerbrugg CH-94-35 ; CH CH-9435 ; 17263216
• MDR Report Key: 3952762
• MDR Text Key: 17291940
• Report Number: 3003974370-2014-00005
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M525 F50
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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