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

Model Number PELORIS II

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 12/18/2014

Event Type  Injury  

Event Description

Leica biosystems received a complaint regarding sub optimal processing of small dermatological samples including shave biopsies from a four hour protocol comprising 176 cassettes, which completed in retort a on (b)(6) 2014.The tissue samples involved were described by the complainant as "brittle" following processing.On (b)(6) 2015, leica biosystems received info that a diagnosis could not be rendered for 14 cases.Further info as to whether re-biopsy had been performed for any pts for whom a diagnosis could not be rendered was sought from the complainant.The age, gender and identifier for any re-biopsied pts were also requested.On (b)(6) 2015, leica biosystems received info that re biopsy for six pts was required.The age, gender, and identifier for each of the re-biopsied pts were provided.Refer to mfr report # 8020030-2015-00003, 8020030-2015-00004, 8020030-2015-00005, 8020030-2015-00006, and 8020030-2015-00007 for specific details of other pts involved.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY LTD; 495 blackburn rd.; mount waverley; melbourne, victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley; melbourne, victoria 3149 ; 92117535
• MDR Report Key: 4531810
• MDR Text Key: 5541201
• Report Number: 8020030-2015-00002
• 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: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2014

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?: Yes
• 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
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 02/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR