MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA CM1850; MICROTOME, CRYOSTAT

Model Number 1491850CE01

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Injury (2348)

Event Date 12/10/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems sevice engineer (fse) was notified by the hospital bio-medical engineer that a user cut his finger while using the leica cm1850.Per the user, the injury occurred on (b)(6) 2015.The user was treated for his injury and provided 4 weeks of prophylactic treatment at the (b)(6) medical center due to the nature of the specimens cut with the instrument.

Event Description

Leica did not receive a response after several attempts to contact the customer for additional information, therefore the investigation of this incident and complaint have been closed by the manufacturer.A follow up report will be submitted if additional information is provided by the customer.A customer facing letter was generated by the manufacturer and will be provided to the customer.

• Brand Name: LEICA CM1850
• Type of Device: MICROTOME, CRYOSTAT
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelberger strasse 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 5380398
• MDR Text Key: 36420123
• Report Number: 1423337-2016-00001
• Device Sequence Number: 1
• Product Code: IDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2016,12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 1491850CE01
• 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: 03/03/2016
• Distributor Facility Aware Date: 12/22/2015
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other