MAUDE Adverse Event Report: LEICA MICROSYSTEMS NUSSLOCH GMBH LEICA CV5030; COVERSLIPPER

Model Number CV5030

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem Tissue Damage (2104)

Event Date 06/16/2014

Event Type  malfunction  

Event Description

The customer reported that the slides were broken during the converslipping process.Consequently, the tissues were damaged because the slides were completely destroyed.As a result, some specimens could not be diagnosed, but no rebiopsy was required.

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 CV5030
• Type of Device: COVERSLIPPER
• 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: 4019475
• MDR Text Key: 4878186
• Report Number: 8010478-2014-00009
• Device Sequence Number: 1
• Product Code: KIM
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CV5030
• Device Catalogue Number: 149CVTS5025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1