MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PELORIS RAPID TISSUE PROCESSOR

Model Number PELORIS 11

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 12/13/2013

Event Type  malfunction  

Event Description

Leica biosystems received a complaint regarding sub-optimal processing of biopsy samples from a two hour protocol.The complainant described the affected tissue samples as "mushy".And advised that the samples had been re-processed.

Manufacturer Narrative

Investigation of this complaint by leica biosystems is in progress.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE; 495 blackburn rd.; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley, victoria 3149 ; 92117400
• MDR Report Key: 3784370
• MDR Text Key: 4360457
• Report Number: 8020030-2014-00001
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/16/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PELORIS 11
• Device Catalogue Number: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2013
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1