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 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.

• 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 (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 ; GM 69226 ; 9622414334
• MDR Report Key: 6489357
• MDR Text Key: 72663010
• Report Number: 8010478-2017-00003
• 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 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

• 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?: Yes
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/13/2017
• Supplement Dates Manufacturer Received: 03/21/2017
• Supplement Dates FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2014
• 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