MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL

Model Number HARHD36

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Abdominal Distention (2601)

Event Date 01/23/2021

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.Additional information was requested and the following was obtained: does the surgeon/author believe the patient consequences reported are associated with the alleged deficiencies of the device? => we was not able to hear the surgeon's though.Is the mentioned video available for review by ethicon engineers and medical personnel? => no.This case was reported from a literature report.We don't obtain the operation video from the surgeon.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 ku hara , takebumi usui, hajime yokomizo , kazuhiko yoshimatsu ,takeshi shimakawa , shunichi shiozawa.Citation:international cancer conference journal (2021) 10:149-153 https:// doi.Org/10.1007 is 13691-021-00468-0.A (b)(6) 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.Reported complication included two months after ladg, she was readmitted to hospital to be treated for chylous ascites and increasing body weight and decreasing serum albumin concentration was not controllable.Percutaneous transabdominal thoracic duct embolization (pttde) was performed on the 8th day after the readmission.

• Brand Name: HARMONIC HD 1000I SHEARS 36CM SHAFT
• 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: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12318290
• MDR Text Key: 266391873
• Report Number: 3005075853-2021-04700
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036015055
• UDI-Public: 10705036015055
• Combination Product (y/n): N
• PMA/PMN Number: K160752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HARHD36
• Device Catalogue Number: HARHD36
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention