MAUDE Adverse Event Report: LEICA BIOSYSTEMS NUSSLOCH GMBH LEICA RM2235

Catalog Number 1492235EUUL

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

The investigation revealed that this incident was user related.The user did forget to lock the handwheel and did not utilize the knife guard while sectioning with the microtome instrument.The injury was not a result of an instrument malfunction.The customer indicated that his finger has healed enough to perform retraining on the rm2235 instrument.A retraining for the user was conducted on (b)(6) 2020.

Event Description

On 20 august 2020, leica biosystems received a complaint that a user was injured during routine sectioning on their microtome, rm2235.The injured user required medical assistance in the form of stitches.

• Brand Name: LEICA RM2235
• Type of Device: LEICA RM2235
• 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: 10545081
• MDR Text Key: 207337866
• Report Number: 8010478-2020-00006
• Device Sequence Number: 1
• Product Code: IDO
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 1492235EUUL
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2017
• 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: 39 YR