MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; ROTARY MICROTOME,

Model Number 1492255UL01

Device Problems Use of Device Problem (1670); Human Factors Issue (2948); Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/07/2015

Event Type  Injury  

Event Description

On (b)(6) 2015 while on-site servicing another instrument, a leica biosystems field service engineer (fse) was notified by a user that earlier in the summer, she cut the end of her finger off while using the leica rm2255.Per the user, the injury occurred on (b)(6) 2015.The user was treated for her injury at (b)(6) and they were able to reattach the end of her finger.This incident was not initially reported to leica biosystems but was reported to the hospital, (b)(6).

Event Description

The leica manufacturer completed their investigation and found that this incident was presumably user related.While the users fingertip was in the cutting area, she activated the cutting process via 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 sent out with recommendation in future to follow the description provided in the instruction for use.

• Brand Name: LEICA RM2255
• Type of Device: ROTARY MICROTOME,
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; 17-19 heidelbergerstr.; nussloch, 69226 ; GM 69226
• MDR Report Key: 5099168
• MDR Text Key: 26589941
• Report Number: 1423337-2015-00018
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 01/29/2016,08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2016
• Distributor Facility Aware Date: 08/24/2015
• Event Location: Hospital
• Date Report to Manufacturer: 01/29/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/30/2016
• 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