MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH HISTOCORE AUTOCUT

Catalog Number 149AUTO00C1

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

The investigation revealed that this incident was user related.User cut a piece of their finger and chipped the bone.The user had not used automated microtomes prior to use of this microtome histocore autocut.The lab technician was not experienced with the advancing feature of the histocore autocut microtome and when she went to remove the block she was roughing she cut herself.The tissue in the block that was in microtome at the time of the incident was not adversely affected.The injury was not a result of an instrument malfunction.The instrument is mechanically and electrically within manufacturers specifications.A retraining for the user was conducted on (b)(6) 2021.

Event Description

On (b)(6) 2021, leica biosystems received a complaint that a user was injured during routine sectioning on their microtome, histocore autocut.The injured user had to be taken to the emergency room and consult with plastic surgeon, and was on medical leave.

Manufacturer Narrative

Additional information: added unique identifier (udi) # in d4.

• Brand Name: HISTOCORE AUTOCUT
• Type of Device: HISTOCORE AUTOCUT
• Manufacturer (Section D): LEICA BIOSYSTEMS NUSSLOCH GMBH; heidelbergerstrasse 17-19; nussloch, 69226 ; GM 69226
• Manufacturer (Section G): LEICA MICROSYSTEMS LTD. SHANGHAI; building 1, 258 jinzang road; shanghai,pudong, 20120 6; CH 201206
• Manufacturer Contact: robert gropp ; heidelbergerstr. 17-19; nussloch, 69226 ; GM 69226
• MDR Report Key: 12180120
• MDR Text Key: 261909130
• Report Number: 8010478-2021-00007
• Device Sequence Number: 1
• Product Code: IDO
• UDI-Device Identifier: 04049188204851
• UDI-Public: (01)04049188204851
• 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,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 149AUTO00C1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR
• Patient Sex: Female