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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP6025 TISSUE PROCESSOR, PRODUCT CODE: IEO

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LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP6025 TISSUE PROCESSOR, PRODUCT CODE: IEO Back to Search Results
Model Number 14049543267
Device Problem Human Factors Issue
Event Date 03/11/2017
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

On march 21, 2017, the customer reported suboptimal tissue after processing on their leica asp6025. As a result, some specimens could not be diagnosed and 10 patients are confirmed to require rebiopsies. Attempts were made to obtain the patient identifier information for the 10 patients who were confirmed to require rebiopsy but the customer declined to provide this information.

 
Manufacturer Narrative

The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site. The customer had used a wrong protocol for the too small biopsies. The logs of the affected instrument were analyzed and no any technical issues were detected. The investigation from application site revealed that the tissues were underprocessed. The provided image from the customer showed that the fatty tissue was still yellow which would indicate that there has been inadequate dehydration and/or clearing, which could lead to underprocessed tissues. Additionally the customer is using sub-x as a xylene substitute. Leica biosystems (b)(4) do not have any validated protocol with sub-x. The customer has to validate the usage of this xylene themselves. Therefore leica biosystems (b)(4) cannot provide nor recommend any protocol along with sub x and (b)(4). If sub x is not exchanged enough it becomes saturated and cannot absorb more. For the same reason leica biosystems (b)(4) do not recommend to use sub x as cleaning xylene because it is not so strong and needs to be changed at least after every 4th runs. A customer facing letter will be sent to the customer with a recommendation in the future of how to properly care for the tissues, reagents and protocols during the processing with the tissue processor.

 
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Brand NameLEICA ASP6025
Type of DeviceTISSUE PROCESSOR, PRODUCT CODE: IEO
Manufacturer (Section D)
LEICA BIOSYSTEMS NUSSLOCH GMBH
heidelbergerstr. 17-19
nussloch, 69226
GM  69226
Manufacturer (Section G)
LEICA INSTRUMENTS (SINGAPORE) PTE. LTD.
12 teban gardens crescent
singapore, 60892 4
SN  608924
Manufacturer Contact
robert gropp
heidelbergerstr. 17-19
nussloch,  69226
  69226
9622414334
MDR Report Key6489357
Report Number8010478-2017-00003
Device Sequence Number1
Product CodeIEO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 03/21/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/13/2017
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/22/2014
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: 04/13/2017 Patient Sequence Number: 1
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