MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

Device Problems No Apparent Adverse Event (3189); Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Hemorrhage/Bleeding (1888); Nausea (1970); Neuropathy (1983); Vomiting (2144); Impaired Healing (2378); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Skin Inflammation/ Irritation (4545)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Exact date unknown, captured as publication year of 2020.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.

Event Description

"title: clinical efficacy of xelox combined with bevacizumab before laparoscopic-assisted radical operation in elderly advanced rectal cancer patients authors: liu jingtian 1, zhao wensheng 1, sun rongxun 1, huang anzhong 1, yu jianping 1 citation: primary health care in china (july 2020); vol.34 no.7: pages 100-102.Doi:10.3969/j.Issn.1001-568x.2020.07.0028.The aim of this retrospective study is to evaluate the clinical efficacy of retroperitoneal laparoscopic assisted radical resection with xelox and bevacizumab in elderly patients with advanced rectal cancer.From january 2012 to march 2014, a total of 66 elderly patients (> 60 years old) with rectal cancer were treated surgically in jinshan hospital.Surgery was performed using scalpel (ethicon).After laparoscopic-assisted radical resection of rectal cancer, the patients were randomly divided into two groups: treatment group (33 cases; 21 males, 12 females, median age 72 years) who received xelox and bevacizumab (bev) treatment before operation, and control group (33 patients; male 18 patients, 15 women, median age 70 years) who received preoperative routine chemotherapy xelox regimen.Reported complications included constipation (n=21), anastomotic leakage (n=5), bleeding (n=9), venous thrombosis (n=9), poor healing of perineal incision (n=14).In conclusion, retroperitoneal laparoscopic assisted radical resection with xelox combined with bevacizumab in elderly patients with rectal cancer can effectively control tumor recurrence, increase 2-year disease-free survival time and improve the quality of life of elderly patients with rectal cancer, which has important clinical significance for elderly patients with rectal cancer." product name: scalpel (ethicon), patient info: "scalpel (ethicon), constipation (n=21), anastomotic leakage (n=5), bleeding (n=9), venous thrombosis (n=9), poor healing of perineal incision (n=14)".Treatment noted: treatment for the events was not reported.Author: "yu jianping jinshan hospital affiliated to fudan university shanghai 201508".

Manufacturer Narrative

(b)(4).Date sent: 7/7/2021.Attempts are being made to obtain the following information.To date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain h6.

Manufacturer Narrative

(b)(4).Date sent: 7/19/2021.Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.¿¿no.Upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 12055173
• MDR Text Key: 267943512
• Report Number: 3005075853-2021-03465
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention