MAUDE Adverse Event Report: THERNO SHANDON LIMITED (TRADING AS THERMO FISHER SCIENTIFIC) THERMO SCIENTIFIC FINESSE ME ELECTRONIC MICROT

Catalog Number 77500102

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 10/13/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a hospital lab in (b)(6) reported to (b)(6) the following: a female lab technician was operating a finesse me microtome (sn (b)(4)).She thought she pressed the stop button, and placed her right hand near the blade.The machine advanced and sliced off part of her finger near the fingernail.She went to the er and the tissue that was cut-off could not be reattached.She was released from the er and went back to work, but later went home due to her finger hurting.The employee spoken to by (b)(6) was from the hospitals biomet/safety department, not the female lab technician.The hospital also reported that they tested the machine "about a 100 times" and could not replicate the issue.The hospital formalized this report to thermo fisher scientific via (b)(6) using mandatory fda 3500a reporting form (appendix 3 8415 medwatch finesse microtome).On (b)(6) 2014, the hospital confirmed the following: "starting with the first block of the day, when switching from the trim mode to the section mode, the user had hit the run button to stop the microtome.She was grabbing for a ribbon but the machine had not stopped and she cut her finger".The root cause was determined as user error.Investigations into the functioning of the instrument suggests the instrument operated as intended.The scenario reported could not be repeated.The only hypothesis for the cause of the incident the user did not depresses the "run" button the second time as thought, thus the instrument did not stop and in continuing its intended operation the user cut their finger.A review of the instrument by the hospitals biomedical engineer showed the instrument operated as intended.Currently the hospital outsources the servicing of the instrument.This outsourcing is tasked independently of thermo fisher scientific.However as a result of the reported incident a usa thermo fisher service technician visited the hospital, the purpose of this visit was to ensure there were no faults in the operation of the instrument that would cause or contribute to the cut finger.The instrument was found to be working as intended and the thermo field service engineer could not recreate the incident as described.

• Brand Name: THERMO SCIENTIFIC FINESSE ME ELECTRONIC MICROT
• Type of Device: FINESSE ME
• Manufacturer (Section D): THERNO SHANDON LIMITED (TRADING AS THERMO FISHER SCIENTIFIC); runcorn, cheshire WA7 1TA; UK WA7 1TA
• Manufacturer (Section G): RICHARD-ALLAN SCIENTIFIC; 4481 campus dr.; kalamazoo MI 49008
• Manufacturer Contact: 4481 campus dr.; kalamazoo, MI 49008
• MDR Report Key: 4360604
• MDR Text Key: 5235005
• Report Number: 1831638-2014-00001
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 11/07/2014,11/03/2014

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 77500102
• 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: 11/10/2014
• Distributor Facility Aware Date: 10/13/2014
• Device Age: 11 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 Outcome(s): Hospitalization