MAUDE Adverse Event Report: SURGICAL INNOVATIONS LTD LOGI; LOGI INSERT (ECOCUT)

Model Number ECO-100

Device Problem Thermal Decomposition of Device (1071)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2022

Event Type  malfunction  

Event Description

A logi insert caused burns to structures that the device was leaning against whilst coagulating.

Event Description

A logi insert caused burns to structures that the device was leaning against whilst coagulating - our initial awareness of the issues.A description from the distributer rep was obtained 24 may 2022 - 'operating surgeon was performing a cut down hernia procedure.During the procedure he used the ecocut scissors to coagulate tissuing using the valleylab ft10 energy generator.The surgeon selected a setting of 30 on coag fulgurate on the generator.It is reported that adjacent tissue to the scissors, appeared to denature, possibly due to heat.The surgeon switched to another brand of scissors to complete the procedure.' no significant patient harm was reported.

• Brand Name: LOGI
• Type of Device: LOGI INSERT (ECOCUT)
• Manufacturer (Section D): SURGICAL INNOVATIONS LTD; clayton wood house; 6 clayton wood bank; leeds, LS16 6QZ; UK LS16 6QZ
• Manufacturer (Section G): SURGICAL INNOVATIONS LTD; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 6QZ; UK LS16 6QZ
• Manufacturer Contact: stephen seed ; clayton wood house; 6 clayton wood bank; leeds, west yorkshire LS16 -6QZ ; UK LS16 6QZ
• MDR Report Key: 14286017
• MDR Text Key: 294910429
• Report Number: 9680952-2022-00035
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECO-100
• Device Lot Number: 735475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other