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.

• 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
• 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

• Type of Report: Initial,Followup
• Report Date: 03/02/2022

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
• Was Device Available for Evaluation?: No Answer Provided
• 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 Treatment Data

Date Received: 02/04/2022 Patient Sequence Number: 1