MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1860UV

Catalog Number 1491860UVUS

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn(s) (1757)

Event Date 01/07/2022

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently underway and a follow up will be submitted should additional information become available following the investigation.

Event Description

A customer reported to leica biosystems on (b)(6) 2022, that they had an incident with a flammable freeze spray in their cm1860uv, cryostat.The employee had to gone to their emergency room with 1st and 2nd degree burns.

Manufacturer Narrative

Based on the information provided, a user error has caused the adverse event.Leica biosystems nussloch has been alerted the customers, not to use flammable freezing spray with the cryostat, since (b)(6) 2019.The affected customer has used a flammable freezing spray from the manufacturer "cardinal", although it was prohibited with clear instruction with part of the field action (reference number of the field action: z-1729-2019) with a clearly visible warning label and update of ifu with detailed explanation and warning hint.He was initially informed about the field action notice with the recall letter and small sticker on (b)(6) 2019 and has also responded with completed recall acknowledgement form on (b)(6) 2019.Afterwards, the larger sticker with additional text and the recall letter has been sent to this customer on (b)(6) 2019 as well.The customer responded the second time with completed recall acknowledgement form on (b)(6) 2019.However, the customer never changed their freeze spray after the recall letter, safety amendment of the instructions for use and the sticker was provided.After the completion of the field action, we had globally no other repeated incident.Because this is a single occurrence, the decision was that no further measures are required in the field.

Manufacturer Narrative

Additional information: added unique identifier (udi) # in d4.

• 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: 13453182
• MDR Text Key: 285152830
• Report Number: 8010478-2022-00001
• 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,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: 1491860UVUS
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2013
• 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