MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV

Catalog Number 1491860UVUS

Device Problem Use of Device Problem (1670)

Patient Problem Burn(s) (1757)

Event Date 10/31/2023

Event Type  Injury  

Event Description

Leica biosystems (lbs) received an inquiry from the complainant, which prompted lbs sales representatives to visit the customer site.On 2 november 2023 while on-site, the lbs sales representatives were informed of an incident where the user of the leica cryostat instrument was sent to the emergency room with second degree burns on her face.The incident occurred on 31 october 2023.The complainant confirmed the lab uses flammable freezing spray inside the cryochamber of the leica cryostat, which then caused the injury to the user.Lbs conducted a cryostat recall (fda recall: (b)(4)) in 2019 because of previously reported adverse events where users were burned because of the use of flammable freezing spray in the cryochamber of the cryostat instrument.The lbs cryostat recall updated the instrument labeling and informed customers that the use of flammable freezing spray is prohibited.The complainant confirmed they were aware of the leica recall on flammable freezing spray from 2019.This is the only occurrence of injury due to this user error post closure of the cryostat recall reported to lbs.

• Brand Name: LEICA CM1860UV
• Type of Device: CM1860UV
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 18235231
• MDR Text Key: 329315519
• Report Number: 3022446399-2023-00010
• Device Sequence Number: 1
• Product Code: IDP
• UDI-Device Identifier: 04049188168481
• UDI-Public: (01)04049188168481
• 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: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 1491860UVUS
• 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: 11/29/2023
• Distributor Facility Aware Date: 11/02/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female