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

Model Number 14049543267

Device Problems Device Operates Differently Than Expected (2913); Human Factors Issue (2948)

Patient Problem Tissue Damage (2104)

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.

• Brand Name: LEICA ASP6025
• Type of Device: TISSUE 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 ; SN 608924 ; 9622414334
• MDR Report Key: 6566190
• MDR Text Key: 75093902
• Report Number: 8010478-2017-00004
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• 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 Received: 05/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other