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

Model Number PELORIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/08/2019

Event Type  Injury  

Event Description

Leica biosystems received a tissue processing complaint of "brittle tissue," which occurred on (b)(6) 2019.The complainant advised that 11 out of 58 cases have not been able to be diagnosed.On 03 december 2019, leica biosystems received the following information in relation to the event on (b)(6) 2019: "there are eleven (11) cases that could potentially have repeat biopsies.Currently, there have been two repeat biopsy cases: (b)(6) y.O./female/vaginal bx and (b)(6) y.O./female/endometrial bx.All cases able to be diagnosed?: no, 11 of 58 cases cannot be diagnosed." the following information was received in relation to the event on (b)(6) 2019: "currently, there have not been any repeat biopsy cases.There is one (1) cases that could potentially have a repeat procedure.All cases able to be diagnosed? no, one case cannot be diagnosed by pathology but was diagnosed by radiology." as of 10 january 2020, leica biosystems has not received any further information in relation to the other undiagnosable cases.Refer to importer report #: 1423337-2020-00002 for specific details on the other patient involved.

• 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
• MDR Report Key: 9576070
• MDR Text Key: 179812564
• Report Number: 1423337-2020-00001
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• 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: 01/10/2020
• Distributor Facility Aware Date: 11/26/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/10/2020
• 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: 71 YR