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

Model Number ASP300S

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 01/16/2014

Event Type  Injury  

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 one pt was necessary.

Manufacturer Narrative

An investigation of the incident is currently underway and a f/u will be submitted should add'l info become available following the investigation.

• Brand Name: LEICA ASP300S
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch 6922 6; GM 69226
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226 ; GM 69226 ; 224143345
• MDR Report Key: 3703698
• MDR Text Key: 4337536
• Report Number: 8010478-2014-00002
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• 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: 02/27/2014

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: Health Professional
• Device Model Number: ASP300S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2014
• Initial Date FDA Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR