MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number LCSXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Failure to Anastomose (1028); Post Operative Wound Infection (2446); Insufficient Information (4580)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event date: publication year of 2017.Batch # unk.(b)(4).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.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: experience in diagnosis and treatment of 21 cases of "three-port" laparoscopic-assisted radical resection of colorectal cancer.Authors: lv junsheng, ma song, zhang pengfei, mu xing, yang jianwei, wu qiuming.Citation cite: doi: 10.3969/j.Issn.1008-1070.2017.11.023.The objective of this study is to investigate the feasibility and clinical value of "three-port" laparoscopic-assisted radical resection of colorectal cancer.The clinical data of 21 patients with "three-port" laparoscopic-assisted radical resection of colorectal cancer (observation group) and 32 patients with conventional laparoscopic radical resection of colorectal cancer (control group) completed in the hospital were retrospectively analyzed.Ethicon ultrasonic scalpel (johnson & johnson, usa) was used.Reported complications included postoperative anastomotic leakage (n=2) ,postoperative incision infection (n=1), anastomotic stricture, erectile dysfunction; (n=1), increased defecation frequency after rectal cancer surgery (n=5).In conclusion "three-hole" laparoscopic-assisted radical resection of colorectal cancer had no significant difference in surgical efficacy compared with "five-hole" laparoscopic radical resection of colon cancer, with less trauma, safety and reliability, reduced labor cost, providing a technical choice for the majority of surgeons.It is worthy of being widely popularized in the clinical application.

Manufacturer Narrative

(b)(4) date sent: 10/14/2022 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.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: INSTRUMENT, ULTRASONIC SURGICAL
• 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: orla o'mahony ; 475 calle c; guaynabo ; 329348013
• MDR Report Key: 15484493
• MDR Text Key: 300586339
• Report Number: 3005075853-2022-06339
• 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: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: LCSXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention