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

Model Number UNKNOWN LIGASURE INSTRUMENT

Device Problem Energy Output Problem (1431)

Patient Problems Abscess (1690); Hemorrhage/Bleeding (1888); Pleural Effusion (2010)

Event Date 07/01/2017

Event Type  Injury  

Manufacturer Narrative

Title: the feasibility of cardiophrenic lymphnode assessment and removal in patients requiring diaphragmatic resection during interval debulking surgery for ovarian cancer source: journal of investigative surgery 2021, vol.34, no.7, 756¿762 published online: 06 dec 2019.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a retrospective study analyzed outcomes of patients who underwent interval debulking surgery with cardiophrenic lymph node resection for ovarian cancer between july 2017 and june 2018.Ligasure was used for diaphragmatic resection and to resect the cardiophrenic lymph nodes.There were 7 patients in the study and complications included intraoperative bleeding (300ml-1000ml) and postoperative subphrenic collection and pleural effusion.Blood transfusions were required.Pleural effusion required drainage.

• 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: 12573284
• MDR Text Key: 274696239
• Report Number: 1717344-2021-01348
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• 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
• Date Manufacturer Received: 09/16/2021
• 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