MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; MICROTOM

Model Number 1492255UL01

Device Problems Human Factors Issue (2948); Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem Injury (2348)

Event Date 07/07/2015

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, the customer reported an injury using a rotary microtome.The user was treated for her injury at (b)(6) and they were able to reattach the end of her finger.

Manufacturer Narrative

This incident was presumably user related.While the users fingertip was in the cutting area, she activated the cutting process by the foot pedal.Safety gloves were not worn, as described in the instruction for use: "when working with microtomes, personal safety precautions must always be taken.It is mandatory to wear work safety shoes, safety gloves, a mask and safety goggles." a customer facing letter will be send out with recommendation in future to follow the description provided in the instruction for use.

• Brand Name: LEICA RM2255
• Type of Device: MICROTOM
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 6224143
• MDR Report Key: 5093857
• MDR Text Key: 26393239
• Report Number: 8010478-2015-00006
• Device Sequence Number: 1
• Product Code: IDO
• 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: Other
• Type of Report: Followup
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1492255UL01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/16/2005
• 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
• Patient Age: 36 YR