MAUDE Adverse Event Report: LEICA MICROSYSTEMS (SCHWEIZ) AG LEICA M320 W12; MICROSCOPE, SURGICAL

Model Number M320 W12

Device Problems Product Quality Problem (1506); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2014

Event Type  malfunction  

Event Description

(b)(4).On 02/06/2015, leica microsystems received a complaint stating that the swing arm of the leica m320 w12 surgical microscope fell to the lowest arm position beside the pt.The surgeon was able to hold on to one of the eye pieces to stop the fall.It was reported that there was no injury to pt or user.The surgical microscope is out of service and the affected part is being shipped to manufacturer for investigation.

Manufacturer Narrative

The mfr report number of the initial report submitted on date 02/20/2015 was erroneously shown as 3003974370-2015-00016.The mfr report number for the event at dr.(b)(6) facility is identified as 3003974370-2015-00001 and had been corrected in section "mft report#".This is a final report.An investigation on the affected part of the surgical microscope (parallelogram) was conducted by the specification developer.Visual inspection and functional eval of the affected component were performed.The malfunction was not reproducible to result in the same damages of screws as reported.It was found that the root cause is that the screws of a component were not properly tightened due to human error at the supplier's mfg site based on investigation at this supplier.There are no indications that the problem is systematic.Based on the results, the probability of occurrence is remote.Therefore the incident can be considered as an isolated event.

• Brand Name: LEICA M320 W12
• Type of Device: MICROSCOPE, SURGICAL
• Manufacturer (Section D): LEICA MICROSYSTEMS (SCHWEIZ) AG; max schmidheiny-strasse 201; heerbrugg 9435 ; SZ 9435
• Manufacturer Contact: roland jehle ; max schmidheiny-strasse 201; heerbrugg CH-94-35 ; SZ CH-9435 ; 17263216
• MDR Report Key: 4620440
• MDR Text Key: 5764876
• Report Number: 3003974370-2015-00001
• 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: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M320 W12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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