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

Catalog Number	14051454200
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation revealed that this incident was user related.The staff did not follow the safety instructions detailed in the instructions for use (ifu).The customer did not wear cut-resistant gloves while cleaning the instrument, as described in the ifu.A customer facing letter will be sent out with recommendation in the future to follow the cleaning and maintenance instructions provided in the instructions for use and to wear cut-resistant gloves.
Event or Problem Description
On 02 october 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
• Common Device Name: HISTOCORE SPECTRA CV
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 10762845
• Report Number: 8010478-2020-00008
• Device Sequence Number: 14376052
• Product Code: KIM
• UDI-Device Identifier: 04049188203953
• UDI-Public: (01)04049188203953
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 14051454200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female