MAUDE Adverse Event Report: THERMO SCIENTIFIC FINESSE; MICROTOME

Model Number FINESSE ME

Device Problem Device Stops Intermittently (1599)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

The histology employee was using the micro-tome device to process a tissue specimen.She pushed the stop button on the micro-tome but it continued to run as she was trying to get a hold of the tissue.The employee's finger was caught in the blade and cut off near tip of her right index finger.

• Brand Name: FINESSE
• Type of Device: MICROTOME
• Manufacturer (Section D): THERMO SCIENTIFIC; kalamazoo MI
• MDR Report Key: 4251828
• MDR Text Key: 4987479
• Report Number: 4251828
• Device Sequence Number: 1
• Product Code: IDO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FINESSE ME
• Device Catalogue Number: 77500102
• Other Device ID Number: HOSP ID-CE4762
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/13/2014
• Device Age: 13 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 51 YR