MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE

Catalog Number LCSXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fever (1858); Hemorrhage/Bleeding (1888); Pain (1994); Vomiting (2144); Multiple Organ Failure (3261); Thrombosis/Thrombus (4440); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2021.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.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 how many of the patients who died had the harmonic device used during the liver dissection procedure?.Does the author/surgeon believe that the ethicon device caused or contributed to the patient deaths?.What were the definitive number of patients who had the ethicon device used in their procedure and experienced each of the complications (i.E.Fever, n=?)?.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: therapeutic efficacy of microwave coagulation versus liver resection for hepatocellular carcinoma within the milan criteria: a propensity score matching analysis authors: hanxin feng, chunbo yang, feng xu, yang zhao, tianqiang jin , zeyuan wei, dexin wang, chaoliu dai citation: european journal of surgical oncology 48 (2022, 418-424; https://doi.Org/10.1016/j.Ejso.2021.08.035 this study aimed to compare the therapeutic efficacy of resection (res) and microwave ablation (mwa) for hepatocellular carcinoma (hcc) within the milan criteria.Between 2011 and 2019, 426 hepatocellular carcinoma patients within the milan criteria who were treated were included in the study.The patients were categorized into the resection group (291 patients) and microwave ablation group (135 patients).In the resection group, there were 229 males and 69 females with a mean age of 56.3 years.Patients in this group underwent open or laparoscopic procedures according to tumor location and patient preference.The liver parenchymal dissection was performed using harmonic synergy blades (ethicon endo-surgery), a competitor¿s bipolar coagulation forceps, or a with the clamp-crushing method with an intermittent pringle maneuver.In the microwave ablation group, there were 95 males and 40 females with a mean age of 57.3 years.Patients in this group underwent a laparoscopic, open, or percutaneous approach with microwave ablation performed using a competitor¿s cooled-shaft system device.The reported complications included fever (n=?), pain (n=?), vomiting (n=?), severe ascites (n=?), portal vein thrombosis (n=?), liver abscess (n=?), bile leakage (n=?), liver failure (n=?), and blood loss (n=?).In conclusion, microwave ablation resulted in survival outcomes that were similar to those of resection for hepatocellular carcinoma within the milan criteria.However, it had more favorable hospital stay and blood loss outcomes than resection.

Manufacturer Narrative

(b)(4).Date sent: 10/25/2022.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.How many of the patients who died had the harmonic device used during the liver dissection procedure?--none.Does the author/surgeon believe that the ethicon device caused or contributed to the patient deaths?--no.What were the definitive number of patients who had the ethicon device used in their procedure and experienced each of the complications (i.E.Fever, n=?)?--unk.H1.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 SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: SOFT-TISSUE ULTRASONIC SURGICAL SYSTEM HANDPIECE TIP, SINGLE-USE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kate karberg ; 475 calle c; guaynabo ; 3035526892
• MDR Report Key: 15539313
• MDR Text Key: 301153195
• Report Number: 3005075853-2022-06677
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/04/2022
• Supplement Dates Manufacturer Received: 10/20/2022
• Supplement Dates FDA Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention