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

Catalog Number HARXX

Device Problem Insufficient Information (3190)

Patient Problems Pyrosis/Heartburn (1883); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nausea (1970); Vomiting (2144)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2019.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: impact of pyloric injection of magnesium sulfate-lidocaine mixture on postoperative nausea and vomiting after laparoscopic sleeve gastrectomy: a randomized-controlled trial.Authors: mohammad fathy, mohamed anwar abdel-razik, ayman elshobaky, sameh hany emile, ghada el-rahmawy, ahmed farid, hosam ghazy elbanna.Citation: obesity surgery, 2019; 29: 1614¿1623.One of the most common adverse effects of laparoscopic sleeve gastrectomy (lsg) is postoperative nausea and vomiting (ponv).The present study aimed to assess the impact of local injection of a mixture of magnesium sulfate and lidocaine into the pylorus on gastric intraluminal pressure (ilp) and ponv after lsg.A total of 70 patients (63 female and 7 male patients; age range: 24 to 56 years old) with morbid obesity who underwent lsg were randomly allocated to one of two equal groups: treatment group (pyloric injection of a mixture of magnesium sulfate and lidocaine) and control group (pyloric injection of normal saline).Ponv and antiemetic requirements were recorded at 6 and 24 hours postoperatively.During the lsg procedure in both groups, a three-port technique was used.Devascularization of the greater curvature of the stomach started 4 cm proximal to the pylorus using a harmonic ace 5-mm sealing device (ethicon).A 36-french bougie was inserted into the stomach then gastric transection started 4 cm proximal to the pylorus using long echelon flex endopath 60-mm endo-stapler (ethicon).In both groups, reported complications included significant post-operative nausea and vomiting at 6 hours (n-38) in which antiemetic treatment was given to the patients, significant post-operative nausea and vomiting at 24 hours (n-14) in which antiemetic treatment was given to the patients, reactionary hemorrhage (n-1) which required laparoscopic intervention to control bleeding points at staple line, surgical site infection (n-4) which were treated with wound drainage and antibiotics, and gastroesophageal reflux disease (n-4) which were treated with proton pump inhibitors and prokinetic agents.The injection of magnesium sulfate-lidocaine mixture in the pylorus after lsg resulted in lower incidence of ponv and less use of antiemetic medications in the first 24 hours after lsg without being associated with higher complication rate.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10278179
• MDR Text Key: 202676013
• Report Number: 3005075853-2020-03581
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K120729
• 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: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• 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: 06/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention