MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE SPECTRA CV

Model Number SAME AS CATALOG NUMBER

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 09/21/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, leica biosystems received a complaint that a user was injured while attempting to clean the shifter and rail on their coverslipper, histocore spectra cv.The injured user had pieces of glass in her finger and visited the emergency room to have the glass removed and then returned to work.No stitches were required.The user was identified as a female in her 20's.

• Brand Name: HISTOCORE SPECTRA CV
• Type of Device: HISTOCORE SPECTRA CV
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 10763299
• MDR Text Key: 213901491
• Report Number: 1423337-2020-00007
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: SAME AS CATALOG NUMBER
• Device Catalogue Number: 14051454200
• 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: 10/30/2020
• Distributor Facility Aware Date: 10/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other