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 Problems Abdominal Distention (2601); Insufficient Information (4580)

Event Date 01/23/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 9/20/2022.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.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: first successful case of percutaneous transabdominal thoracic duct embolization (pttde) for chylous ascites resulting from laparoscopic gastric cancer surgery authors: hideyuki yokokawa, takao katsube, miki miyazawa, ryohei nishiguchi, shinichi asaka, kentaro yamaguchi, minoru murayama, kotaro kuhara, takebumi usui, hajime yokomizo, kazuhiko yoshimatsu, takeshi shimakawa, shunichi shiozawa.Citation cite: international cancer conference journal (2021) 10:149¿153 https://doi.Org/10.1007/s13691-021-00468-0.A 61-year-old woman was admitted to our hospital for treatment of gastric cancer.Preoperative examination showed that the tumor was located in the middle part of the stomach and had invaded the muscularis propria (mp) but without lymph node metastasis.She underwent ladg with extragastric lymph node dissection (d2) using laparoscopic ultrasonic shears (harmonic scalpel; ethicon endo-surgery, cincinnati, oh, usa).Billroth i gastroduodenostomy was performed, and a drain was placed under the left lobe of the liver from the right upper abdomen.On postoperative day 2, the patient was allowed oral intake of food.The drain was removed at postoperative day 3.The postoperative course was uneventful and she was discharged at postoperative day 14.Two months after ladg, she was readmitted to hospital reported complications included abdominal distension, chylous ascites.In conclusion this is the first case of successful treatment by pttde of chylous ascites caused by laparoscopic gastric cancer surgery.No complications were observed after lymphangiography or pttde.Lymphography and pttde for postoperative chylous ascites proved to be safe and effective treatments.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 15458659
• MDR Text Key: 300298474
• Report Number: 3005075853-2022-06278
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120729
• 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: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention