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

Catalog Number HARXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Necrosis (1971)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2021, exact date unk.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: application value of ultrasonic scalpel in modified radical mastectomy and axillary lymph node dissection in patients with breast cancer.Author: haihui sheng.Citation: medical equipment (january 2021); vol.34, no.2: 64-65.Https://www.Cnki.Net.The aim of this study is to investigate the effect of ultrasonic scalpel in modified radical mastectomy and axillary lymphadenectomy in patients with breast cancer.From january 2017 to june 2020, a total of 70 patients with breast cancer admitted to haimen people's hospital were included in the study.These patients were randomly divided into experimental group (35 patients; mean age = 52.5 ± 2.3; age range = 30 to 84 years) and control group (35 patients; average age = 51.1 ± 1.6; age range = 30 to 84 years).The control group was treated with modified radical mastectomy and axillary lymphadenectomy with conventional electrocautery, while the experimental group was treated with modified radical mastectomy and axillary lymph node dissection assisted by ultrasonic scalpel (ethicon, model gen11).Reported complication includes flap necrosis (n=1).In conclusion, modified radical mastectomy and axillary lymphadenectomy with ultrasonic scalpel in breast cancer patients can achieve satisfactory results, and the incidence of postoperative complications is low." product: "ultrasonic scalpel (ethicon), gen 11 (ethicon)".Patient info: "ultrasonic scalpel (ethicon) and gen 11 (ethicon): flap necrosis (n=1)".Treatment noted: treatment for the events was not reported.Author: "haihui sheng.Haimen people's hospital (haimen, jiangsu province 226100)".

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: 12055118
• MDR Text Key: 268827404
• Report Number: 3005075853-2021-03471
• 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
• 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): Other