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 Problem Paralysis (1997)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Title outcomes of sutureless total thyroidectomy in elderly source international journal of surgery, volume 33, 2016 (s16-s19) date of publication: 8 june 2016.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed between 2008 and december 2014, thyroid disease is common in elderly population.The incidence of hypothyroidism and multinodular goiter increases with age.Surgery in elderly patients has been considered to be more hazardous than in a youthful population.Besides the traditional surgical hemostatic techniques, different hemostatic approaches, which further minimize the risk of bleeding and complications during thyroidectomy, have become available.Aim of the study was to review and compare the outcomes of total thyroidectomy (tt) in elderly performed with different energy system.Such as none, ligasure precise/small jaw or a non-medtronic product.Total of 255 patients were eligible for the study and enrolled.One hundred and five patients with age >70 years constituted the elderly group (eg), whereas the young group (yg) was composed by 150 patients.Recurrent transient paralysis occurred in one patient in ligasure young patient group.Transient recurrent laryngeal nerve palsy was observed 1 ligasure young patient.Hematoma was observed in 1 ligasure young 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: 9183987
• MDR Text Key: 163551738
• Report Number: 1717344-2019-01328
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/14/2019
• 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 Age: 56 YR