MAUDE Adverse Event Report: LEICA MICROSYSTEMS SCHWEIZ AG LEICA M525 F40; MICROSCOPE, SURGICAL

Model Number M525 F40

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/11/2015

Event Type  malfunction  

Event Description

(b)(4).Leica microsystems (b)(4) received a complaint on march 12, 2015 from (b)(6) stating that on (b)(6) 2015 the xenon lamp turned off during surgery.This happed due to the lamp house door which was bent and could therefore not be closed properly.The back-up illumination was burnt and not functional.The surgery was continued and completed with another surgical microscope.

Manufacturer Narrative

This is an initial and final report.The manufacturer investigated the complaint.Visual inspection was performed by a field service engineer and results showed that the malfunction could be attributed to a bent lamp open door the xeno lamp turned off.The back-up illumination was burnt at this time and not functional.The surgery was continued/completed with another device.As described in the user manual (leica m525 f40 ref.10 714 384/ version b), the illumination shall be checked prior to surgery.In addition the user manual describes that an operation shall never be performed with only one functioning illumination and that a defective lamp shall be replaced at the next opportunity.The reported malfunction could have been detected prior to use if the instruction in the user manual was followed.

• Brand Name: LEICA M525 F40
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS SCHWEIZ AG; max schmidheinystrasse 201; heerbrugg 9435 ; CH 9435
• Manufacturer Contact: max schmidheinystrasse 201; heerbrugg 9435 ; 17263216
• MDR Report Key: 4655637
• MDR Text Key: 20148182
• Report Number: 3003974370-2015-00004
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M525 F40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1