MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2255; MICROTOM, PRODUCT CODE: IDO

Model Number 1492255UL01

Device Problem Human Factors Issue (2948)

Patient Problem Injury (2348)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

The investigation revealed the following: this incident is user related because the user disregarded the safety instructions.The customer forgot to engage the lock and did not use the safety cover for the blade.The injury was not an instrument malfunction.A safety training was performed with the customer to avoid this injury in future.

Event Description

On (b)(6) 2017, leica biosystems received a complaint that a customer injured his finger during the usage of the microtome.Medical treatment was necessary.

• Brand Name: LEICA RM2255
• Type of Device: MICROTOM, PRODUCT CODE: IDO
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17; nussloch, 69226 ; GM 69226
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 7099263
• MDR Text Key: 94223035
• Report Number: 8010478-2017-00008
• 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: Initial
• Report Date: 11/10/2017

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: No Information
• Device Model Number: 1492255UL01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2016
• 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