MAUDE Adverse Event Report: LEICA MICROSYSTEMS SCHWEIZ AG LEICA M844 F40

Model Number M844 F40

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Head Injury (1879)

Event Date 12/15/2014

Event Type  Injury  

Event Description

(b)(4).Leica microsystems (b)(4) received a complaint on (b)(6) 2014 from (b)(6) stating that on (b)(6) 2014, before an ocular surgery, the leica binocular tube fell onto the patient's forehead causing a lump.

Manufacturer Narrative

This is an initial and final report.Before an ocular surgery, the leica binocular tube fell onto the patient's forehead causing a lump.The manufacturer investigated the complaint.Photographic inspection was performed and results showed that the malfunction could be attributed to an interoperability problem most likely caused by another device.However, photo showed that the leica binocular tube, which fell, was attached to a surgical microscope eye safety filter, which is a device that is not manufactured by leica.In addition, the screw used with the surgical microscope eye safety filter was not supplied or manufactured by leica.

• Brand Name: LEICA M844 F40
• Manufacturer (Section D): LEICA MICROSYSTEMS SCHWEIZ AG; max schmidheinystrasse 201; heerbrugg 0000 ; CH 0000
• Manufacturer Contact: max schmidheinystrasse 201; heerbrugg 0000 ; 17263216
• MDR Report Key: 4396082
• MDR Text Key: 5123815
• Report Number: 3003974370-2014-00015
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M844 F40
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR