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 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 (4) 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 patient(s) were also requested.On (b)(6) 2015, leica biosystems received info that re-biopsy of six (6) patients was required.The age, gender and identifier for each of the re-biopsied patients were provided.Refer to mfr report#: 8020030-2015-00002, 8020030-2015-00003, 8020030-2015-00004, 8020030-2015-00006 and 8020030-2015-00007 for specific details of the other patients involved.

• Brand Name: PELORIS RAPID TISSUE PROCESSOR
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS MELBOURNE PTY. LTD; 495 blackburn rd.; mount waverley, victoria 3149 ; AS 3149
• Manufacturer Contact: 495 blackburn rd.; mount waverley, victoria 3149 ; 92117535
• MDR Report Key: 4531790
• MDR Text Key: 22039197
• Report Number: 8020030-2015-00005
• 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?: 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
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 02/16/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR