MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE GSU-22; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number FORCEGSU-22

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

Patient Problems Abscess (1690); Sepsis (2067)

Event Date 12/05/2016

Event Type  Death  

Manufacturer Narrative

Title: abandoning prophylactic abdominal drainage after hepatic surgery: 10 years of no-drain policy in an enhanced recovery after surgery environment source: dig surg 2017;34:411¿420.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between 2005¿2014, routine prophylactic abdominal drainage after hepatic surgery is still being debated, as it may be unnecessary, possibly harmful, and uncomfortable for patients.The aim of this study was to examine the postoperative complication and reintervention rates in patients undergoing liver resection that were treated without prophylactic drains in an eras (enhanced recovery after surgery)environment.All hepatectomies performed without prophylactic drainage were included.Mortality within 90 days after surgery was observed in 15 patients (2.8%).Within this group, 5 patients died from sepsis following an intra-abdominal abscess or biloma.

• Brand Name: FORCE GSU-22
• 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: 11633424
• MDR Text Key: 244390204
• Report Number: 1717344-2021-00535
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEGSU-22
• Device Catalogue Number: FORCEGSU-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 64 YR