MAUDE Adverse Event Report: LEICA MICROSYSTEMS NUSSLOCH GMBH LEICA ASP300S; TISSUE PROCESSOR

Model Number 14047643514

Device Problems Human-Device Interface Problem (2949); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 08/12/2015

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional info become available following the investigation.

Event Description

On (b)(6) 2015, the customer reported suboptimal tissue after processing on their leica asp300.As a result, some specimens could not be diagnosed and one pt is confirmed to require rebiopsy.

Manufacturer Narrative

The unit has been evaluated by a leica application specialist.The investigation revealed the following: the root cause is determined to be the usage of a basket without the anti-reflection clip and a dirty level sensor.After the event the level sensors were cleaned and the anti-reflection clip installed, the customer conducted a new processing run which confirmed the proper functioning of the unit.A customer facing letter will be sent to the customer with the reference in future to follow the recommendation in the customer letter regarding the usage of the anti-reflection clip and the periodic cleaning of the level sensors.This final report is in reference to the initial report 8010478-2015-0004.

• Brand Name: LEICA ASP300S
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA MICROSYSTEMS NUSSLOCH GMBH; heidelberger str. 17-19; nussloch 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226 ; GM 69226 ; 224143345
• MDR Report Key: 5073841
• MDR Text Key: 25850954
• Report Number: 8010478-2015-00004
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 08/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 14047643514
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 83 YR