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

Model Number CV5030

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 08/19/2014

Event Type  Injury  

Event Description

The customer reported that one slide was destroyed during the coverslipping process.Consequently, the specimen was damaged and could not be diagnosed.As a result, a new 'pap smear' of one pt was necessary.

Manufacturer Narrative

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

• Brand Name: LEICA CV5030
• Type of Device: COVERSLIPPER
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger str. 17-19; nussloch 6922 6
• Manufacturer Contact: robert gropp ; heidelberger str. 17-19; nussloch 69226
• MDR Report Key: 4202113
• MDR Text Key: 4979525
• Report Number: 8010478-2014-00012
• Device Sequence Number: 1
• Product Code: KIM
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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
• Type of Report: Initial
• Report Date: 08/20/2014

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: CV5030
• Device Catalogue Number: 14047839700
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/21/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other