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  

Manufacturer Narrative

Lbs conducted a cryostat recall (fda recall: z-1729-2019) 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.

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 (b)(6) 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.

• Brand Name: LEICA CM1860UV
• Type of Device: CM1860UV
• 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
• MDR Report Key: 18247669
• MDR Text Key: 329497233
• Report Number: 8010478-2023-00016
• Device Sequence Number: 1
• Product Code: IDP
• UDI-Device Identifier: 04049188168481
• UDI-Public: (01)04049188168481
• 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
• Report Date: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1491860UVUS
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female