MAUDE Adverse Event Report: LEICA MICROSYSTEMS NUSSLOCH GMBH LEICA TP1020; TISSUE PROCESSOR

Model Number TP1020

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 06/24/2014

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 two patient was necessary.

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.

• Brand Name: LEICA TP1020
• Type of Device: TISSUE PROCESSOR
• Manufacturer (Section D): LEICA MICROSYSTEMS NUSSLOCH GMBH; heidelberger str. 17-19; nussloch 6922 6; GM 69226
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226 ; GM 69226 ; 224143345
• MDR Report Key: 3987040
• MDR Text Key: 4820752
• Report Number: 8010478-2014-00010
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/24/2014

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: Other
• Device Model Number: TP1020
• Device Catalogue Number: 14042230543
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other