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

Model Number UNKNOWN PENCIL

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

Patient Problems Hematoma (1884); Seroma (2069); Numbness (2415); Post Operative Wound Infection (2446)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Title: evaluation of ultrasonic axillary dissection in preservation of intercostobrachial nerve and lymphatic sealing in breast cancer patients: randomized controlled trial source: annals of medicine and surgery 60 (2020) 255¿260 available online 1 november 2020, 2049-0801/© 2020 the authors.Published by elsevier ltd on behalf of ijs publishing group ltd.(http://creativecommons.Org/licenses/by/4.0/).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the literature, a prospective study analyzed post-operative complications in 40 patients who underwent breast surgery for breast cancer between january 2017 and september 2019.The harmonic scalpel was used for axillary lymph node dissection (alns) in 20 patients and electrocautery was used alns in 20 patients.In all patients, electrocautery was used to create the skin flaps and separate the breast together with pectoral fascia from the underlying pectoralis major muscle.Post-operative complications in patients who underwent alns with electrocautery were: hematoma, seroma, wound infection and axillary numbness.Interventions for the complications were not specified.

• Brand Name: UNKNOWN PENCIL
• 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: 11120518
• MDR Text Key: 225263458
• Report Number: 1717344-2021-00014
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PENCIL
• Device Catalogue Number: UNKNOWN PENCIL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• 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): Required Intervention