MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER UNKNOWN LIGASURE INSTRUMENT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number UNKNOWN LIGASURE INSTRUMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Perforation of Esophagus (2399)

Event Date 12/09/2020

Event Type  Injury  

Manufacturer Narrative

Title: short- and long-term outcomes of thoracoscopic pneumonectomy  single center experience source: videosurgery miniinv 2021; 16 (2): 369376 doi: https://doi.Org/10.5114/wiitm.2021.103923.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study compared the outcomes of video-assisted thoracoscopic pneumonectomy in patients with lung cancer between september 2010 and january 2020.Ligasure or another device were used for soft tissue dissection and lymphadenectomy.There were 19 patients in the study and complications included bleeding (800ml), stapling the suction catheter tipinto the bronchial staple line, esophageal perforation and air leak in the bronchial stump.Conversion to open was required to resolve the bleeding and to remove the catheter tip from the staple line.Reoperations were required to treat the esophageal perforation.The air leak in the bronchial stump was sutured intraoperatively and confirmed to be airtight.

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12425236
• MDR Text Key: 270041858
• Report Number: 1717344-2021-01219
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN LIGASURE INSTRUMENT
• Device Catalogue Number: UNKNOWN LIGASURE INSTRUMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR