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

Model Number 1491850CE01

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

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

Event Date 12/10/2015

Event Type  Injury  

Manufacturer Narrative

An investigation of the incident is currently ongoing and a follow up including the outcome of the investigation will be submitted.

Event Description

On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems service engineer (fse) was notified by the hospital bio-med that a user cut their 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) department at (b)(6) center due to the nature of the specimens cut with the instrument.

Manufacturer Narrative

The customer initially provided a response to the incident; however, because leica did not receive a response after several attempts to contact the customer for additional information, the investigation of this incident and complaint have been closed.

• Brand Name: LEICA CM1850
• Type of Device: MICROTOME, CRYOSTAT, PRODUCT CODE IDP
• 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 ; 6224143345
• MDR Report Key: 5382425
• MDR Text Key: 36466526
• Report Number: 8010478-2016-00001
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• 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
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other