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

Model Number 14049543267

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

A field safety corrective action has been initiated by the manufacturer.Leica biosystems is issuing the field safety notice (fsn) to inform the customer about a field safety corrective action (fsca) that we are initiating, to address an issue we have experienced with our tissue processor, (b)(4).

Event Description

The (b)(4) is sporadically and incorrectly getting into the wrong instrument state "bottle empty" during retort filling.This potentially leads to suboptimal quality of processed tissue.In some cases, a re-biopsy of the patient could be necessary in order to obtain another viable tissue sample.

• Brand Name: LEICA ASP6025
• Type of Device: AUTOMATED TISSUE PROCESSOR
• Manufacturer (Section D): LEICA BIOSYSTEMS 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: 4996469
• MDR Text Key: 23932144
• Report Number: 8010478-2015-00003
• Device Sequence Number: 1
• Product Code: IEO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Report Date: 07/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 14049543267
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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