MAUDE Adverse Event Report: LEICA MICROSYSTEMS SCHWEIZ AG LEICA M525 F50

Model Number M525 F50

Device Problems Electrical /Electronic Property Problem (1198); Device Issue (2379); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2015

Event Type  malfunction  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should add'l info become available following the investigation.

Event Description

Leica microsystems ((b)(4)) ag received a complaint from (b)(6) on july 19, stating there was an error w/a m525 f50 surgical microscope.The illumination of the surgical microscope did not work and the brakes of the stand could not be operated during surgery.The surgeon was able to complete the surgery.There was no patient or user harmed.

Manufacturer Narrative

This is a final report.An investigation was conducted on two printed circuit board assemblies (control and suppression board) by the specification developer.Visual inspection and functional/electrical evaluation of the electrical components were performed.As a result of the investigation, it was identified that one printed circuit board assembly (control board) was defective and one printed circuit board assembly (suppression board) worked according to specification.The defective printed circuit board assembly was caused by a shorted capacitor.Consequently a short circuit occurred and caused the malfunction of the device.It was shown that the defective component (capacitor) on the printed circuit board assembly had a crack.Based on the investigation results it was found that a probable root cause is an external force that resulted in such a crack of the capacitor.The definite root cause could not be determined.The occurrence of the failure was evaluated.Based on the results, it showed that the occurrence of the probable root cause was very remote.Therefore the incident can be considered as an isolated event.

Manufacturer Narrative

This is a follow-up report.The defective parts of the affected device were investigated by specification developer.An electrical evaluation was performed and confirmed that one of the parts (control board of f50) is defective.Further investigation will be performed by the responsible supplier of the board.The final report will be submitted once the investigation is completed.

• Brand Name: LEICA M525 F50
• Manufacturer (Section D): LEICA MICROSYSTEMS SCHWEIZ AG; max schmidheinystrasse 201; heerbrugg, st. gallen (sg) 09435 , SZ; CH 09435, SZ
• Manufacturer Contact: roland jehle ; max schmidheinystrasse 201; heerbrugg, st. gallen 9435 ; SZ 9435 ; 1717263216
• MDR Report Key: 5015791
• MDR Text Key: 25490846
• Report Number: 3003974370-2015-00006
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: BL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Physician
• Report Date: 07/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: M525 F50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other