MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA ASP6025; TISSUE PROCESSOR

Model Number ASP6025

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/05/2014

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 after processing the tissue samples had been sub-optimally processed.As a result, some specimens could not be diagnosed.A rebiopsy of two patients was necessary.

• Brand Name: LEICA ASP6025
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger str. 17-19; nussloch 6922 6; GM 69226
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226 ; GM 69226
• MDR Report Key: 3885781
• MDR Text Key: 15952771
• Report Number: 8010478-2014-00008
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASP6025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other