MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M530 OH6; SURGIAL MICROSCOPE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ulceration (2116); Injury (2348)

Event Date 03/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).An investigation of the incident is currently underway and a follow-up will be submitted should additional information become available following investigation.

Event Description

On (b)(6) 2018, leica microsystems ((b)(6)) ag received a complaint from the (b)(6) stating that three (3) patients had skin ulcerations and one (1) patient had thermal burn immediately following surgery.For this report one patient had skin ulceration immediately following surgery.See manufacturer/importer report numbers: 3003974370-2018-00007 / 3003974370-2018-00008 / 3003974370-2018-00010 for information regarding the other three (3) patients reported in the complaint.

Manufacturer Narrative

Exemption number e2011008.Leica microsystems (schweiz) ag (the manufacturer) is submitting the report on behalf of leica microsystems, inc.(b)(4).This is a final report.Leica microsystems (schweiz) ag performed visual inspection and functional test on the actual device.The results were as follows: the m530 oh6 has brightcare protection installed which reduces the light intensity automatically as the working distance decreases.This minimizes potential incidents of patient burns.This system engages by default upon microscope startup.The brightcare system was shown to be active upon examination and functioning properly.All filters were in the proper location within the m530 oh6 and were shown to be functioning correctly.An examination of the infrared (ir) heat protection filter showed, that the ir filter of the m530 oh6 functioned according to specifications.A check of the device history record showed that the device was functioning according to specifications and revealed no anomalies during manufacturing, in-process controls and final acceptance test.A review of the complaint databank showed, that leica microsystems (schweiz) ag is not aware of any other similar incident since introduction of the m530 oh6.Based on the investigation results and the review of the complaint databank we conclude, that the m530 oh6 functions correctly and that it is highly unlikely that it caused or contributed to the incident.

• Brand Name: LEICA M530 OH6
• Type of Device: SURGIAL MICROSCOPE
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max-schmidheiny-strasse 201; heerbrugg, sankt gallen 9435 ; SZ 9435
• MDR Report Key: 7725441
• MDR Text Key: 115189720
• Report Number: 3003974370-2018-00009
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/02/2018
• Device Age: 11 MO
• Event Location: Hospital
• Date Manufacturer Received: 07/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 MO