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

Model Number PELORIS

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/07/2015

Event Type  Injury  

Event Description

Leica biosystems was advised that "tissue dried out on a run but wasn't discovered until 2 days after, the instrument has operated correctly since".On (b)(6) 2015, leica biosystems received information that re-biopsy of one (1) patient was necessary.The age and gender of the affected patient was provided.Investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

The initial 30-day fda 3500a report cited (b)(6) 2015 as the date of event (mm/dd/yyyy).Investigation of this complaint determined the actual date of event (mm/dd/yyyy) is (b)(6) 2015.Based on the information provided, it was determined that the sub-optimal tissue processing reported is derived from the "factory 8hr xylene standard" protocol started in retort a at 16:23pm on (b)(6) 2015, which completed at 06:58am on (b)(6) 2015; and the "factory 12hr xylene standard" protocol started in retort b at 17:13pm on (b)(6) 2015, which completed at 10:58am on (b)(6) 2015.No use error(s) was identified in the instrument log in relation to the interaction between the user and the instrument either prior to, or during execution of the "factory 8hr xylene standard" protocol started in retort a at 16:23pm on (b)(6) 2015 and the "factory 12hr xylene standard" protocol started in retort b at 17:13pm on (b)(6) 2015, from which sub-optimal tissue processing was reported.The root cause of the sub-optimal tissue processing reported could not be determined from the information available.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, victoria 3149 ; AS 3149 ; 3 9211753
• MDR Report Key: 5006509
• MDR Text Key: 23089735
• Report Number: 8020030-2015-00071
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/05/2007
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR