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

Model Number UNKNOWN LIGASURE INSTRUMENT

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

Patient Problems Pulmonary Embolism (1498); Arrhythmia (1721); Fistula (1862); Paralysis (1997)

Event Date 08/22/2020

Event Type  Injury  

Manufacturer Narrative

Title: dissection with ligasure impact¿ versus conventional resection in pylorus-preserving partial pancreatoduodenectomy (dissect): a single-institution randomized controlled trial source: langenbeck's archives of surgery https://doi.Org/10.1007/s00423-020-01968-y.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature study performed between september 2009 and february 2012 to analyze 86 patients in a randomized controlled trial who underwent pylorus preserving partial pancreatoduodenectomy at a single-center.The ¿per protocol¿ group included 56 patients: ligasure (28) and conventional (28).Complications for all of the ligasure patients in both of the study arms include: postoperative pancreatic fistula (6 patients), leakage of hepaticojejunostomy (4 patients), re-intervention (19 patients), burst abdomen (1 patient), pulmonary embolism (1 patient), acute renal failure (1 patient), cardiac rhythm disorder (1 patient) and paralysis (1 patient).

• Brand Name: UNKNOWN LIGASURE INSTRUMENT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10710649
• MDR Text Key: 212261281
• Report Number: 1717344-2020-01241
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• 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: 09/30/2020
• 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): Other
• Patient Age: 65 YR