MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number ACEXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Vomiting (2144); Hernia (2240); Insufficient Information (4580)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4), date sent: 3/1/2024.B3: publication year of 2023.D4: 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: reconstruction of the phreno-esophageal ligament (r-pel) prevents the intrathoracic migration (itm) after concomitant sleeve gastrectomy and hiatal hernia repair.Author(s): i.Hutopila, m.Ciocoiu, l.Paunescu, c.Copaescu.Citation: surgical endoscopy; https://doi.Org/10.1007/s00464-022-09829-z.The main objective of the study was to evaluate the efficiency of the concomitant hiatal hernia repair with or without partial reconstruction of phreno-esophageal ligament to prevent intrathoracic gastric migration after laparoscopic sleeve gastrectomy.The secondary objectives focused on the procedure¿s metabolic and gastro esophageal reflux disease-related outcomes.Between january 2016 and january 2019, 273 patients (95 male and 178 female) who underwent concurrent hiatal hernia repair and laparoscopic sleeve gastrectomy were included in the study (group a and b, 146 and 127 patients).The mean age and bmi were 42.6 ± 11.3 and 43.4 ± 6.8 kg/m2.Group a included patients receiving crura approximation only and group b patients with partial reconstruction of phreno-esophageal ligament.In both groups, laparoscopic sleeve gastrectomy procedure, the gastric greater curvature was dissected using a competitor bipolar vessel sealer (manufacturer: medtronic) or a harmonic ace ultrasonic scalpel (ethicon endo-surgery).For the crural approximation during the hiatal hernia repair, 3 to 4 2.0 prolene (ethicon) monofilament crossing stitches were placed for the posterior cruroplasty.6 to 8 cartridges were used for laparoscopic sleeve gastrectomy, trimming up the stomach from 1 to 2 cm before the pylorus to 1 to 2 cm below the hiss angle, along a 35 french calibration bougie.The staplers¿ height was selected according to the gastric wall thickness using either a competitor¿s tri-staple (manufacturer: medtronic) or echelon gst (ethicon endo-surgery).The entire stapled line was routinely oversewn using 3.0 non-resorbable monofilament suture (prolene, ethicon).For all the patients in group b, who underwent laparoscopic sleeve gastrectomy procedure and hiatal hernia repair, since 2018, a partial reconstruction of the phreno-esophageal ligament was added.To achieve this task, the esophageal wall was stitched to the surrounding diaphragm 3 cm proximal to the gastroesophageal junction, at the level of original insertion of the phreno-esophageal ligament.2 seromuscular non-absorbable 3.0 sutures (prolene, ethicon) were placed at 9 o¿clock and 3 o¿clock, on the right and, respectively, left side of the esophagus aiming to create the condition to develop a connective structure between the esophagus and diaphragm, which will act as the original phreno-esophageal ligament.Reported complications intrathoracic migration with transitory episodes of vomiting during the early postoperative course (n=?), medio-gastric stenosis (n=?), de novo gastroesophageal reflux disease at 1 year postoperative (n=?), de novo severe esophagitis at 1 year postoperative (n=?).In conclusion, concurrent laparoscopic sleeve gastrectomy and hiatal hernia repair by crura approximation only has a very high rate of intrathoracic migration in the first postoperative year (over 50 percent).Partial reconstruction of phreno-esophageal ligament is an innovative technique which proved to be very efficient in preventing intrathoracic migration after hiatal hernia repair.

• Brand Name: ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18816830
• MDR Text Key: 336739355
• Report Number: 3005075853-2024-01799
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: RO
• PMA/PMN Number: K051036
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention