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

Catalog Number 14051454200

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 09/21/2020

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 213937403
• Report Number: 8010478-2020-00008
• Device Sequence Number: 1
• Product Code: KIM
• UDI-Device Identifier: 04049188203953
• UDI-Public: (01)04049188203953
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 14051454200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/30/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female