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

Model Number PELORIS

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 12/13/2016

Event Type  Injury  

Event Description

Leica biosystems received a complaint that biopsy samples from a tissue processing run were under-processed.On 13 december 2016, leica biosystems received information that re-biopsy of two (2) male patients will be required.It was also documented that the institution was not prepared to provide any further patient details.Investigation of this complaint by leica biosystems is in progress and if additional information becomes available a follow up report will be submitted.Refer to importer report numbers 1423337-2016-00032 and 1423337-2016-00033 for all patients involved.

Event Description

Following the leica biosystems manufacturer's investigation of this complaint, it was found that the instrument operated within specification.The root cause of the sub-optimal tissue processing reported was a use error.Specifically, a user failed to complete manual replacement of a reagent in accordance with the manufacturer instructions detailed in the leica peloris/peloris ll user manual, which contains the following specific warning: "always change reagents when prompted.Always update station details correctly - never update the details without replacing the reagent.Failure to follow these directives can lead to tissue damage or loss." see manufacturer follow up reports 8020030-2016-00090 and 8020030-2016-00091 for more specific information regarding the investigation of this complaint.

• 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
• MDR Report Key: 6199589
• MDR Text Key: 63133140
• Report Number: 1423337-2016-00032
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2017,12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PELORIS
• Device Catalogue Number: 26.0005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/20/2017
• Distributor Facility Aware Date: 12/13/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/20/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other