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 Fistula (1862); Hemorrhage/Bleeding (1888); Pleural Effusion (2010); Abdominal Distention (2601)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2020, 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

"title: comparison of the effect of ultrasonic scalpel and clamp in the treatment of giant hepatic hemangioma author/s: zhu yingzhe, wang jitao.The objective of this study was to compare the effect of two methods of liver amputation (ultrasonic scalpel and clamping) in the treatment of giant hepatic hemangioma.From january 2013 to december 2018, 62 patients with giant hepatic hemangioma who underwent surgery were included.Mean age (41.4 ± 10.95) years old (range 18-65 years), including 37 males and 25 females.According to the method of liver tissue transection, the patients were divided into two groups: n=33 ultrasonic scalpel (us group) and n=29 clamp method (cc group).The operative methods were divided into nonanatomical hepatectomy (including hemangioma dissection) and anatomic hepatectomy.The specific operative methods were determined according to the patient's general condition, tumor diameter, location, adjacent relationship with the first and second hepatic hilum and the volume of residual liver.The former refers to dissecting the perihepatic ligament sufficiently according to the need of operation, exposing the liver in the area to be resected, separating along the boundary between the tumor and the normal liver tissue, dissecting the hemangioma completely from the liver by ultrasonic scalpel or clamping step by step, and resecting part of the liver tissue if necessary.The latter refers to the concept of anatomical hepatectomy to remove the hemangioma and the liver tissue of the glis-son system, including segmentectomy, lobectomy, (left and right) hemihepatectomy and extended hemihepatectomy.Selective occlusion of the hepatic hilum was performed as necessary during the radical operation, with the first occlusion.The scalpels used in the scalpel group were purchased from johnson & johnson inc., usa, main.The pre-tangent line was marked on the surface of the liver with an electrotome, and the parenchymal tissue of the liver was cut inwardly from the surface of the liver with a harmonic scalpel, and the blood vessels < 3 mm in diameter were directly clotted with the ultrasonic scalpel.The bile ducts or vessels = 3 mm in diameter were severed after silk ligation.The clamp group was treated with traditional metal clamps and threads.The basic procedure was the same as that of the ultrasonic scalpel group.When the liver was severed, the liver parenchyma was bluntly pressed and separated by vascular forceps, the intrahepatic blood vessels and biliary.All 62 patients completed the operation smoothly without perioperative death.There was no significant difference in the liver resection time between the two groups, and there was no significant difference in liver function, hospitalization days and follow-up between the two groups on the 5th postoperative day.Reported postoperative complications included in the ultrasonic scalpel (us) group included n=1 abdominal hemorrhage, n=1 intraperitoneal hemorrhage, n=3 biliary fistula, n=2 pleural effusion, n=1 infection and n=1 incision fat liquefaction.In conclusion, the operation of giant hepatic hemangioma with ultrasonic scalpel can reduce the bleeding during hepatectomy, reduce the damage of liver function and accelerate the recovery of liver function, but there is no significant difference between the two methods in perioperative and long-term treatment." product name: harmonic scalpel (johnson&johnson).Patient info: "harmonic scalpel.N=1 abdominal hemorrhage.N=1 intraperitoneal hemorrhage.N=3 biliary fistula.N=2 pleural effusion.N=1 infection.N=1 incision fat liquefaction." treatment noted: "postoperative intraperitoneal hemorrhage occurred in 3 patients (1 in the us group and 2 in the cc group), which was stopped after conservative treatment.Treatment for the other events was not reported." author: "zhu yingzhe department of surgery, general hospital of xingtai mimng conglomerate of the jizhong energy group co.,ltd.,xingtai 054000,china".

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: 12054823
• MDR Text Key: 268699765
• Report Number: 3005075853-2021-03469
• 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): Required Intervention