MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M720 OH5; MICROSCOPE, SURGICAL

Model Number M720 OH5

Device Problems Unintended Movement (3026); Noise, Audible (3273)

Patient Problems Injury (2348); Coma (2417)

Event Date 04/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, leica microsystems received a complaint stating that during a surgical procedure (brain tumor resection), the base brake of the leica m720 oh5 surgical microscope allegedly released by itself.The incident apparently caused a loud noise and slight vibrations.It is not yet known which one of the effects, if any, led the surgeon to rupture the intracerebral carotid artery of the patient.

Manufacturer Narrative

Once allowed access by the end-user facility, leica representatives immediately conducted an initial visual inspection of the affected actual device at the end user facility on (b)(4) 2014.Preliminary results from the initial visual inspection show inconclusive information to the root cause.Therefore, further investigation is required to determine the root cause.The surgical microscope is located at the end-user facility and is out of service.

• Brand Name: LEICA M720 OH5
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max schmidheiny-strasse 201; heerbrugg 9435 ; SZ 9435
• Manufacturer Contact: max schmidheiny-strasse 201; heerbrugg 9435 ; 17263216
• MDR Report Key: 3778185
• MDR Text Key: 4438870
• Report Number: 3003974370-2014-00003
• Device Sequence Number: 1
• Product Code: EPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M720 OH5
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 10 YR