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

Model Number PELORIS II

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 05/05/2017

Event Type  Injury  

Event Description

Leica biosystems received a complaint of under processed tissue as a result of a tissue processing run.On (b)(6) 2017, leica biosystems received information that a number of cases from this event were not diagnosable and rebiopsy of three (3) patients had occurred.A request for an identifier, age/date of birth and gender for each patient for whom re-biopsy has been performed, was made by the leica representative in contact with the lab manager.As of 02 june 2017, the specific patient identifier information for the three (3) patients rebiopsied has not been provided to leica.A follow up report will be submitted if/when additional information is provided.

• 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: 6608425
• MDR Text Key: 76545837
• Report Number: 1423337-2017-00009
• 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: 06/02/2017,05/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2017
• Distributor Facility Aware Date: 05/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other