MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC ACE 5MM SHEAR; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number HARXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); Blood Loss (2597); Thromboembolism (2654); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 12/11/2019.Date of event: publication year of 2016.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.

Event Description

Title: three-port laparoscopic sleeve gastrectomy: a novel technical modification.Author/s: gretchen dunford, do, sunu philip, md, and kerry kole, do.Citation: surg laparosc endosc percutan tech 2016;26:e174¿e177.The purpose of this technical report was to describe the performance of a sleeve gastrectomy using only 3 ports.A total of 100 patients [n=20 male, n=80 female, mean age 43 years (range 19-69 years), mean bmi 47.6 kg/m2 (range 34-74 kg/m2)] had undergone laparoscopic sleeve gastrectomy (lsg) using a 3-port technique over a 1-year period at a single institution.Branches of the gastroepiploic arcade to the gastric wall are then divided using an ultrasonic dissector (harmonic scalpel; ethicon endo-surgery).This portion of the procedure was performed entirely with the ultrasonic dissector and was greatly facilitated by upward traction exerted with the left hand through the right upper quadrant port.Thirty-day postoperative complications included venous thromboembolism (n=2); bleeding (n=1) that did not require reoperation; and transient obstruction of the sleeve remnant (n=1) that was treated with endoscopy and dilation.More postoperative pain, wound complications and the final cosmetic outcome remain the principal disadvantages of a multiport technique especially when many large trocars are used.The use of this 3-port technique in selected patients may bridge the gap and offset these disadvantages.

• Brand Name: HARMONIC ACE 5MM SHEAR
• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9454462
• MDR Text Key: 188194450
• Report Number: 3005075853-2019-24193
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention