MAUDE Adverse Event Report: LEICA BIOSYSTEMS RICHMOND, INC. ARIOL SL-200 SCANNING SYSTEM; NONE

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 04/30/2015

Event Type  malfunction  

Event Description

Customer reported the following issues with the ariol sl-200 scanning system: persistent inconsistencies in frame illumination (changes in color and brightness) in the same scan.Inconsistency in the count number of target events.Variability in overall brightness between different scans.

Manufacturer Narrative

The device is still under investigation.Follow up report will be sent upon receipt of additional information.

• Brand Name: ARIOL SL-200 SCANNING SYSTEM
• Type of Device: NONE
• Manufacturer (Section D): LEICA BIOSYSTEMS RICHMOND, INC.; richmond
• Manufacturer Contact: joseph consoli ; 5205 route 12; richmond, IL 60071 ; 8156782000
• MDR Report Key: 4810849
• MDR Text Key: 5923933
• Report Number: 1419341-2015-00002
• Device Sequence Number: 1
• Product Code: NTH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K043519
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2012
• 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