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

Model Number 149CVTS5025

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 04/20/2016

Event Type  Injury  

Event Description

On april 22, 2016 leica biosystems received a complaint that a user's finger was cut while retrieving broken glass slides from inside the unit.Stitches were required to close the cut.The manufacturer is currently still investigating this incident and a follow up report will be submitted once this is complete.Patient identifier information was also requested from the customer but to date, the lab manager did not want to provide this information.If this or additional information is received, a follow up report will be submitted.

Event Description

Following the investigation by the leica manufacturer, the conclusion is that the incident was possibly related to a temporary impairment of the instrument output rack elevator.The issue could not be replicated on-site by the leica field service engineer.The leica engineer aligned the instrument output rack elevator, cleaned the instrument and performed a test run to verify the operation without further issue.The test run passed.On (b)(6) 2016, leica biosystems received information that the injured lab technician was a female in her 50's.No other specific patient identifier information was provided.

• Brand Name: LEICA CV5030
• Type of Device: COVERSLIPPER
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 5653709
• MDR Text Key: 45150820
• Report Number: 1423337-2016-00003
• Device Sequence Number: 1
• Product Code: KIM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/14/2016,04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 149CVTS5025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2016
• Distributor Facility Aware Date: 04/22/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other