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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 Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/23/2018
Event Type  Injury  
Event Description
Leica biosystems received a complaint regarding "bad processing" of tissue samples.On 23 february 2018, leica biosystems received information that a case was not diagnosable.As of 16 march 2018 - information, as to whether a re-biopsy was recommended or performed and the patient identifier information, has not been provided to leica biosystems.If additional information is received a follow up report will be submitted.
 
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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 Key7346590
MDR Text Key102717173
Report Number1423337-2018-00003
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 02/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2018
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 FDA02/23/2018
Distributor Facility Aware Date02/23/2018
Event Location Other
Date Report to Manufacturer02/23/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
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