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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300S

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300S Back to Search Results
Model Number 14047643514
Device Problem Human Factors Issue
Event Date 04/13/2018
Event Type  Injury  
Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.

 
Event Description

The customer reported that on (b)(6) 2018 they experienced suboptimal tissue processing on their asp300s. As a result five biopsies were undiagnosable. A re-biopsy was recommended, but to date the patients have been received no re-biopsy.

 
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Brand NameLEICA ASP300S
Type of DeviceASP300S
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstr. 17-19
nussloch, 69226
GM  69226
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch,  69226
  69226
MDR Report Key7513574
Report Number8010478-2018-00002
Device Sequence Number1
Product CodeIEO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Device MODEL Number14047643514
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 Received04/18/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/31/2007
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: 05/15/2018 Patient Sequence Number: 1
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