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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025

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LEICA BIOSYSTEMS NUSSLOCH GMBH ASP6025 Back to Search Results
Model Number 14049543267
Device Problem Human Factors Issue
Event Date 11/15/2017
Event Type  Injury  
Manufacturer Narrative

An investigation of the event is currently underway and it will be submitted in a follow-up report.

 
Event Description

The customer reported that on (b)(6) 2017 they experienced suboptimal tissue processing on their asp6025. As a result for around 100 small samples were undiagnosable.

 
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Brand NameASP6025
Type of DeviceASP6025
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstr. 17-19
nussloch, 69226
GM  69226
Manufacturer Contact
robert gropp
building 1, 258 jinzang road
pudong, shanghai,  20120-6
  201206
MDR Report Key7116384
Report Number8010478-2017-00009
Device Sequence Number1
Product CodeIEO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number14049543267
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/20/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/04/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/14/2017 Patient Sequence Number: 1
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