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

Model Number PELORIS II

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 11/30/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, leica biosystems received a complaint regarding undiagnosed tissue.Also on 30 november 2017, leica biosystems received the case details for two (2) patients for whom tissue was not diagnosable.Refer to report number 1423337-2017-00021 for detail of 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; victoria, 3149 ; AS 3149
• MDR Report Key: 7144643
• MDR Text Key: 95724181
• Report Number: 1423337-2017-00022
• 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: 12/22/2017,11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• 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: 12/22/2017
• Distributor Facility Aware Date: 11/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other