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

Model Number M530 OHX

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2021

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) ag received a complaint from usa stating that the light of the m530 ohx turned off in the middle of a procedure.There was no patient injury reported.The procedure was completed with the same device as they were able to restart the microscope and enable all functions as normal.

Manufacturer Narrative

This is a final report.An investigation of the reported incident where the light of an ohx turned off in the middle of the procedure was conducted.On an initial investigation performed by the fse on the actual device it was not possible to reproduce the reported issue.The reported issue was not seen by the fse and subsequent follow up revealed no problem with the affected device.A deeper investigation on a representative ohx was performed by an sme to check for abnormal power shutdown in the attempt to simulate the failure mode and subsequently determine the root cause.A test with 4 hrs of burn-in did not reveal any issue, there was no abnormal shutdown of the ohx.A review of the complaint database and reportable events for identification of any potential adverse trends was performed.The review did not reveal any indications for an adverse trend.There are no similar cases known.The observed problem could not be reproduced.The device is working properly and no further issues were observed by the hospital.Based on this it can be concluded that the observed issue was not caused by the device.Based on a review of the complaint database the issue can be considered an isolated event with no indications of an adverse trend.The root cause could not be determined.Environmental influences (e.G.Interruption of mains power) cannot be ruled out.The fse found no problem with the device.There were no parts exchanged.

• Brand Name: M530 OHX
• 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: 11299460
• MDR Text Key: 252209018
• Report Number: 3003974370-2021-00002
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M530 OHX
• Device Catalogue Number: 10448704
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1