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

Model Number PELORIS II

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

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

Event Date 09/21/2016

Event Type  Injury  

Event Description

Leica biosystems received a complaint that processed tissue cassettes showed poor morphology.On (b)(6) 2016, leica biosystems received confirmation that seven cases from that processing run had to be rebiopsied.Patient identifier information was provided for all cases and separate reports have also been submitted for all cases.Report numbers for all cases are as follows: 1423337-2016-00010, 1423337-2016-00011, 1423337-2016-00012, 1423337-2016-00013, 1423337-2016-00014, 1423337-2016-00015 and 1423337-2016-00016.Please refer to these reports for specific details of the other patients involved.

Event Description

Following the investigation by the leica manufacturer, the root cause of the sub-optimal tissue processing could not be determined from the information available.No use error(s) was identified in the instrument logs and no instrument failure was detected; the device operated within specification.See manufacturer report 8020030-2016-00068, 8020030-2016-00069, 8020030-2016-00070, 8020030-2016-00071, 8020030-2016-00072, 8020030-2016-00073 or 8020030-2016-00074 for more information.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: PELORIS II
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD.; 495 blackburn road; mount waverley; victoria, 3149 ; AS 3149
• MDR Report Key: 6031624
• MDR Text Key: 57550445
• Report Number: 1423337-2016-00013
• 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
• Type of Report: Initial,Followup
• Report Date: 11/11/2016,09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2016
• Distributor Facility Aware Date: 09/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 11/11/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR