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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 Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Tissue Damage (2104); Injury (2348)
Event Date 11/30/2016
Event Type  Injury  
Event Description
On (b)(6) 2016, leica biosystems received information that one (1) case was not diagnosable.It was reported that the pathologist had stated that the tissue was of questionable quality prior to processing and it was unknown whether the circumstances involved in this complaint contributed to the recommendation for re-biopsy.It was also not known whether the recommended rebiopsy had been performed.Leica biosystems was advised by the complainant that the reported sub-optimal tissue processing may have been caused by human error.
 
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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 Key6193187
MDR Text Key62957629
Report Number1423337-2016-00031
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 12/21/2016,11/30/2016
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 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 FDA12/21/2016
Distributor Facility Aware Date11/30/2016
Event Location Hospital
Date Report to Manufacturer12/21/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age90 YR
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