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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR
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LEICA BIOSYSTEMS MELBOURNE PTY. LTD. PELORIS RAPID TISSUE PROCESSOR; AUTOMATED TISSUE PROCESSOR Back to Search Results
Model Number PELORIS II
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/19/2018
Event Type  Injury  
Event Description
On (b)(6) 2018, leica biosystems received information that two (2) cases involving skin samples were not diagnosable and re-biopsy had been recommended for both patients.On 30 march 2018, leica biosystems received patient identifier information for the two (2) patients for whom re-biopsy was recommended.Refer to importer report number 1423337-2018-00005 for details on the other patient involved.
 
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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 Key7419383
MDR Text Key105115284
Report Number1423337-2018-00004
Device Sequence Number1
Product Code IEO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/10/2018,03/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberPELORIS II
Device Catalogue Number26.0008
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/2018
Distributor Facility Aware Date03/19/2018
Event Location Hospital
Date Report to Manufacturer04/10/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age68 YR
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