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

Model Number PELORIS II

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/21/2017

Event Type  malfunction  

Event Description

Leica biosystems received a complaint that "over processed" tissue samples had been identified from a three (3) hour protocol.When notifying leica biosystems of this complaint, the complainant also stated that: "tissue diagnosed, but that it was hard for the doctors to diagnose." investigation of this complaint by leica biosystems is in progress.

Manufacturer Narrative

Corrected data: (b)(4) was documented in error in evaluation codes of the initial report previously submitted.The instrument logs were downloaded for manufacturer investigation on 22 may 2017.Although the complainant did not provide specific details for the three (3) hour protocol from which sub-optimal processing had been identified, information in the instrument logs indicates that the affected protocol was likely to have been either the "3 hour" protocol comprising 42 cassettes, which started in retort a at 18:24 pm on (b)(6) 2017 and completed at 04:00 am on (b)(6) 2017 or the 3 hour" protocol comprising 50 cassettes, which started in retort a at 15:55 pm on (b)(6) 2017 and completed at 04:02 am on (b)(6) 2017.No use error(s) was identified in the interaction between the user and instrument either prior to, or during, execution of the "3 hour" protocols started in retort a at 18:24 pm on (b)(6) 2017 and at 15:55 pm on (b)(6) 2017.Review of the reagents used during the execution of the "3 hour" protocols started in retort a at 18:24 pm on (b)(6) 2017 and at 15:55 pm on (b)(6) 2017 showed that all reagents had been used for at least four (4) previous processing runs without reported incident.The instrument was found to have operated within specification during execution of the "3 hour" protocols started in retort a at 18:24 pm on (b)(6) 2017 and at 15:55 pm on (b)(6) 2017.The root cause of the sub-optimal tissue processing reported by the complainant 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, 3149 ; AS 3149
• Manufacturer (Section G): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley, 3149 ; AS 3149
• Manufacturer Contact: adrienne hardisty ; 495 blackburn road; mount waverley, 3149 ; AS 3149 ; 92117535
• MDR Report Key: 6579918
• MDR Text Key: 75730473
• Report Number: 8020030-2017-00030
• 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,Followup
• Report Date: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2017
• 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: 26.0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2012
• 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