MAUDE Adverse Event Report: VISION BIOSYSTEMS MELBOURNE PTY LTD. PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR

Model Number PELORIS II

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2015

Event Type  malfunction  

Event Description

Leica biosystems received a complaint regarding intermittent problems with the instrument with running processing protocols overnight.On 03/26/2015, leica biosystems received info that no tissue sample(s) was adversely affected by the circumstances involved in this complaint.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): VISION BIOSYSTEMS MELBOURNE PTY LTD.; 495 blackburn rd.; mount waverley; melbourne, victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley; melbourne, victoria 3149 ; 92117535
• MDR Report Key: 4751410
• MDR Text Key: 5826549
• Report Number: 8020030-2015-00031
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS II
• Device Catalogue Number: 26.0003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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