• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 02/12/2017
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

The customer reported that on (b)(6) 2017 they experienced suboptimal tissue processing on their leica asp6025. Leica biosystems was initially notified by the customer on 17 april 2017 of the suboptimal tissue processing and that some specimens could not be diagnosed and as a result one patient is confirmed to require rebiopsy.

 
Manufacturer Narrative

The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site. The customer processed the tissues, which were all different sizes (some small biopsies), using the "standard tissue overnight" protocol. It is recommended to use at least 5mm (thickness) tissues for the overnight tissue processing protocol, therefore it was determined the customer used the incorrect protocol for processing small tissue biopsies. Following the investigation of the instrument logs and tissue processing information provided by the customer, the leica biosystems (b)(4) applications department determined the use of the incorrect protocol for the size of the tissues processed may result in underprocessed tissue. The image provided by the customer showed that the fatty tissue was still yellow. Additionally, the customer is using sub-x as a xylene substitute in combination with autorotation function. Leica biosystems (b)(4) does not have a validated protocol with sub-x for the (b)(4) instrument. Therefore leica biosystems (b)(4) cannot provide nor recommend any protocol for use of sub x on the (b)(4). 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.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Contact
robert gropp
12 teban gardens crescent
singapore,  60892-4
  608924
9622414334
MDR Report Key6566190
Report Number8010478-2017-00004
Device Sequence Number1
Product CodeIEO
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2017
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 Received04/17/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/30/2015
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: 05/15/2017 Patient Sequence Number: 1
-
-