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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LEXION MEDICAL, LLC LEXION INSUFLOWPORT 5MM SIZE TROCAR (P/N 4100-S; INSUFFLATOR, LAPAROSCOPIC
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LEXION MEDICAL, LLC LEXION INSUFLOWPORT 5MM SIZE TROCAR (P/N 4100-S; INSUFFLATOR, LAPAROSCOPIC Back to Search Results
Model Number 4100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Swelling (2091); Burn, Thermal (2530)
Event Date 05/08/2019
Event Type  malfunction  
Event Description
On (b)(6) 2019, a lexion insuflowport 5mm size trocar (p/n 4100-s) was utilized on a pt during a laparoscopic surgery.During this procedure, the pt developed a burn and blister on their skin near the incision site (abdomen) due to potential heat from the port.Lexion reported after the incident, there has been one other occurrence of potential overheating of the lexion insuflow port during surgery.Lab testing conducted by lexion for further inspection of the device has determined after extended periods of time, pt skin exposer to the external head of the port could produce minor skin irritation.(b)(4).
 
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Brand Name
LEXION INSUFLOWPORT 5MM SIZE TROCAR (P/N 4100-S
Type of Device
INSUFFLATOR, LAPAROSCOPIC
Manufacturer (Section D)
LEXION MEDICAL, LLC
st. paul MN 55103
MDR Report Key8624072
MDR Text Key145738348
Report NumberMW5086746
Device Sequence Number1
Product Code HIF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/12/2024
Device Model Number4100
Device Catalogue Number4100-5XE
Device Lot Number082042002
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/17/2019
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age57 YR
Patient Weight78
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