MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG M525 OPTICS CARRIER; MICROSCOPE, SURGICAL

Model Number LEICA M525 OH4

Device Problems Sparking (2595); Noise, Audible (3273)

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

Event Date 07/06/2021

Event Type  malfunction  

Event Description

A loud bang was heard after microscope was turned on.Nurse saw a blue light or spark and made a sizzling sound.The microscope was powered off, unplugged and removed from the room.It was later discovered that the bulb exploded inside the machine.The microscope was not used on the patient.

• Brand Name: M525 OPTICS CARRIER
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; 1700 leider ln; buffalo grove IL 60089
• MDR Report Key: 12149082
• MDR Text Key: 260957030
• Report Number: 12149082
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LEICA M525 OH4
• Device Catalogue Number: 000000000010448300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1