MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CV5030; COVERSLIPPER, PRODUCT CODE: KIM

Model Number 149CVTS5025

Device Problem Break (1069)

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

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently ongoing.A follow up including the outcome of the investigation will be submitted.

Event Description

On (b)(6) 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.Patient identifier information was also requested from the customer but to date, the (b)(6) did not want to provide this information.

Manufacturer Narrative

The investigation revealed the following: the incident was possibly related due to a short temporary impairment of the output rack elevator.The field service engineer could not be replicated the issue at customer site.The filed service engineer aligned the output rack elevator via service software, cleaned the instrument and performed a test run to verify the operation without further issues.The test run passed.

• Brand Name: LEICA CV5030
• Type of Device: COVERSLIPPER, PRODUCT CODE: KIM
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 6224143345
• MDR Report Key: 5665881
• MDR Text Key: 45473267
• Report Number: 8010478-2016-00002
• Device Sequence Number: 1
• Product Code: KIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2016

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: 149CVTS5025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2016
• Initial Date FDA Received: 05/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2008
• 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
• Patient Outcome(s): Other
• Patient Age: 50 YR