MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number LCSXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Cancer (3262)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2019.Batch # unk.Additional information was requested and the following was obtained: does the author/surgeon believe that the harmonic devices mentioned in this article caused/contributed to the reported events in the article? no additional information can be provided.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.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: a comparison of colonoscopy - assisted trans anal minimally invasive surgery via glove port and endoscopic submucosal dissection in the treatment of early rectal tumors.Author: yaojin, liao xiujun, mao weiming, wu wnejing, yu yanyan, yang guangen citation: chin i gastrointest surg, july 2019, vol.22, no.7.The objective of this study is to explore the safety and feasibility of colonoscopy-assisted transanal minimally invasive surgery via glove port (ca-tamis-gp) in the treatment of early rectal tumors.From july 2013 to march 2017, patients were divided into treatment group and the control group.The treatment group (n=32) underwent (ca-tamis-gp) including 19 males and 13 females with a mean age of 55.6¿11.2 years while the control group (n=35) underwent endoscopic submucosal dissection (esd) including 20 males and 15 females with a mean age of 52.9 ¿12.3 years.The treatment group used an ultrasonic scalpel (harmonic, ace36e, johnson & johnson medical, usa).Mild anal pain (n=6).Mild hematochezia symptoms occurred after surgery and stopped spontaneously after defecation (n=?).Patient diagnosed with adenocarcinoma (pathology was duration) were recommended for radical treatment.In summary, ca-tamis-gp is safe and feasible for the treatment of early rectal lesions, as a more economical and simple surgical approach, with some room for clinical application.However, this study has some limitations, and small sample devices and other unknown factors may introduce bias.These need to be further supported by multicenter and larger studies.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15270754
• MDR Text Key: 298387807
• Report Number: 3005075853-2022-05483
• 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
• Report Date: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• 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
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention