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 Fever (1858); Fistula (1862); Unspecified Infection (1930); Unintended Radiation Exposure (4565)

Event Date 12/29/2021

Event Type  Injury  

Manufacturer Narrative

Title: incidence and risk factors for postoperative pancreatic fistula in 2089 patients treated by radical gastrectomy: a prospective multicenter cohort study in china source: international journal of surgery 98 (2022) 106219.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a prospective study aimed to determine the incidence of clinically relevant postoperative pancreatic fistula (cr-popf) in patients who underwent gastrectomy for gastric cancer between december 2017 and november 2018.Ligasure or other non-medtronic devices were used.There were 2089 patients in the study and ligasure was used in 57 patients.Postoperative complications in the ligasure group non clinically relevant popf in 54 patients and cr-popf in 3 patients.The authors state that ¿the use of ligasure was an independent factor for the occurrence of cr-popf as well as a predictor identifying cr-popf from bl." other complication in patients where device was not specified included: stomach fistula, fever, intraabdominal infection, and intraabdominal fluid collection.Extended drain, antibiotics or other medication were required to treat intraabdominal infection.Intra-abdominal fluid collection required ultrasound-guided intra-abdominal puncture and antibiotics.

• 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: 13434142
• MDR Text Key: 284959805
• Report Number: 1717344-2022-00134
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/14/2022
• Initial Date FDA Received: 02/02/2022
• 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