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

Model Number 1492255UL01

Device Problem Human Factors Issue (2948)

Patient Problem Injury (2348)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

The investigation revealed the following: this incident is presumably user related because the user did disregard the safety instructions.The customer did not wear gloves during the usage of the instrument in the manual mode as described in the instruction for use.A customer facing letter will be sent to the customer with a recommendation in the future to follow the description provided in the instruction for use.

Event Description

On (b)(6) 2016, leica biosystems received a complaint that a customer injured her finger during usage of the microtome.Medical treatment was necessary.

• Brand Name: LEICA RM2255
• Type of Device: MICROTOM, PRODUCT CODE: IDO, PRODUCT CODE: IDO
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstr. 17; nussloch 69226, gm, ; GM
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226 ; 9622414334
• MDR Report Key: 6259451
• MDR Text Key: 65025174
• Report Number: 8010478-2017-00001
• 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: 12/21/2016

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
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2010
• 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