• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ETHICON ENDO-SURGERY, LLC. HARMONIC HD 1000I SHEARS 36CM SHAFT; INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key12318290
MDR Text Key266391873
Report Number3005075853-2021-04700
Device Sequence Number1
Product Code LFL
UDI-Device Identifier10705036015055
UDI-Public10705036015055
Combination Product (y/n)N
PMA/PMN Number
K160752
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHARHD36
Device Catalogue NumberHARHD36
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/19/2021
Initial Date FDA Received08/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Treatment
GENERATOR
Patient Outcome(s) Required Intervention;
-
-