MAUDE Adverse Event Report: LEICA MICROSYSTEMS LEICA MICROSYSTEMS; LEICA M525 F50

Model Number M525 F50

Device Problems Failure to Conduct (1114); Electrical /Electronic Property Problem (1198); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Date 03/28/2016

Event Type  malfunction  

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.

Event Description

Leica microsystems ((b)(4)) received a complaint on the (b)(6) 2016 from (b)(6) stating that the fuse of the main switch on a leica m525 f50 surgical microscope system blew during surgery.The surgeon continued the surgery by replacing the fuse during the procedure and therefore he was able to complete successfully the case by using the affected device.There was no patient/user harm reported.

Manufacturer Narrative

This is a final report.An investigation on a representative sample has been performed by the specification developer due to the fact that no parts were returned.Based on theoretical analysis and tests performed by the specification developer the results show that the reported malfunction was caused by the main fuse of the system which tripped.The exact root cause of the blown fuse could not be determined because the reported malfunction was not reproducible.According to theoretical analysis it is most likely that over a long time voltage spikes on the main line triggered the voltage dependend resistor (vdr) in the unit, which became low impedance and thus triggered the fuse.Or the main fuse has been pre-damaged in the past by an overcurrent.Based on a review of the complaint statistic the probability of occurrence is evaluated as remote and the event has been considered as an isolated event.The affected device is still in use and needs not be repaired because the or staff replaced the fuse already during surgery and device works according to specification.

Manufacturer Narrative

The previously reported manufacturing site information was missing and therefore the manufacturing site's address, fax number and email address are being submitted.

• Brand Name: LEICA MICROSYSTEMS
• Type of Device: LEICA M525 F50
• Manufacturer (Section D): LEICA MICROSYSTEMS; max schmidheiny strasse 201; heerbrugg,, st. gallen 9435 ; SZ 9435
• Manufacturer Contact: roland jehle ; 12 teban gardens crescent; singapore, 60892-4 ; SN 608924 ; 1717263216
• MDR Report Key: 5570287
• MDR Text Key: 42437824
• Report Number: 3003974370-2016-00006
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Reuse
• Patient Sequence Number: 1