MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP300S

Model Number 14047643514

Device Problems Human Factors Issue (2948); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Tissue Damage (2104)

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.

Manufacturer Narrative

The investigation revealed the following: the incident was presumably user related due to a wrong application from the customer site.The logs of the affected unit has been investigated by a leica application & product specialist.The analysis of the instrument revealed that there was no technical failure of the device found which would have led to nondiagnosable tissues.The analysis showed that the customer began the tissue processing with a delay step in the first alcohol (70%).It is not recommended to start processing tissue in alcohol because this may dehydrate the tissue and cause it to become hard/brittle, especially when set in a delay step over a weekend.In addition, there is a pressure and vacuum step in every step.This makes sense only in the wax step.Otherwise, the high pressure can overstress the tissue and could be damaged.These protocol issues are not recommended and caused the suboptimal processed tissues.A customer facing letter will be send to the customer with a recommendation in the future of how to properly care for the tissues, and to modify the protocol regarding the improvement of the tissue quality during the processing with the tissue processor.

• Brand Name: LEICA ASP300S
• Type of Device: ASP300S
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 7513574
• MDR Text Key: 108226541
• Report Number: 8010478-2018-00002
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 14047643514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2007
• 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