MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M525 F50; SURGIAL MICROSCOPE

Device Problems Electrical /Electronic Property Problem (1198); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/20/2019

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 investigation.

Event Description

Leica microsystems (schweiz) (b)(4) received a complaint from (b)(6) stating that during surgery both lamps of the m525 f50 turned off.There was no patient injury reported.The surgery was completed with another device.

Manufacturer Narrative

This is a final report.The root cause why both lamps of the m525 f50 turned off during surgery could not be determined.An investigation of the reported behaviour was not possible as the customer refused access to the allegedly defective parts.The fse checked the service records if there were any indications out of previous service activites which could explain the complaint.Nothing was found which could explain the complaint.A review of the complaint statistic did not reveal any adverse trend for the m525.During a meeting with the customer the fse did a final attempt to get access to the allegedly defective parts for investigation.The customer stated, that there have been surgeries several times a day and the issue has not reoccurred since the event in (b)(6) 2019.Based on the unavailability of the defective parts together with the information of the customer, that the device is in daily use without issues, the complaint investigation will be closed as "ntf" (no trouble found) without further in-depth investigation.

• Brand Name: LEICA M525 F50
• Type of Device: SURGIAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, 9435 ; SZ 9435
• MDR Report Key: 8788000
• MDR Text Key: 150971003
• Report Number: 3003974370-2019-00004
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1