MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ENSEAL GENERIC PRODUCT CODE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number NSEALXXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Hernia (2240); Post Operative Wound Infection (2446)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2020.Batch #: unknown.(b)(4).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.

Event Description

Title: incisional hernia after 2498 single-port access (spa) gynecologic surgery over a 10-year period.Author/s: joseph j.Noh, tae-hyun kim, chul-jung kim & tae-joong kim.Citation: https://doi.Org/10.1038/s41598-020-74.This study aimed to analyze the perioperative outcomes with focus on the incidence of postoperative incisional hernia from our cumulative data of 2498 spa surgeries.There were 2498 korean patients who received spa surgeri3005075853-2021-04917 es for various gynecologic diseases from may 2008 to december 2018 were reviewed.The median age of the patients was 40.3 ¿ 9.2 years, and the mean body mass index (bmi) was 22.6 ¿ 3.2 kg/m2.All patients underwent spa surgeries under general anesthesia.Antibiotic prophylaxis with 1 g cefazolin was administered routinely 30 min before the skin incision.Repeated intraoperative doses of antibiotics were also given for prolonged operations, obese patients, and in cases with severe blood loss at anesthesiologists discretion.The spa laparoscopic surgeries were performed in the same surgical procedures and steps by the two surgeons.After incising the skin at about 2.02.5 cm, subcutaneous tissue and anterior abdominal fascia were opened by bovie electrocauterization in 40-w, monopolar coagulation mode (bovie medical corporation, inc., melville, ny, usa) using the open hasson technique.Entering the peritoneum, a singleport access was created by inserting a polyurethane multi-channel single-port system.The previously described platform which consisted of a wound retractor and a surgical glove was used during the earlier period of the study then it was replaced by a number of commercial platforms including the one port (lapakorea, inc., seoul, south korea), octo port (dalimsurgnet, inc., seoul, south korea), sils port (covidien, inc., norwalk, ct, usa) and labsingle (sejong medical, inc., paju, south korea).The carbon dioxide pneumoperitoneum was kept at 13 mmhg throughout the operations.The instruments used during the operations included monopolar scissors, laparoscopic energy devices such as enseal (ethicon, inc., somerville, nj, usa), thunderbeat (olympus, inc., tokyo, japan), or ligasure (medtronic, inc., minneapolis, mn, usa), myoma screws, laparoscopic needle holders and articulating graspers (roticulator, covidien, inc., norwalk, ct, usa).After the completion of all stitches, the port-system was removed.Then the knots were tied sequentially from outer side of the incision.The peritoneum was not closed as a separate layer.The fascial defect was closed using 2-0 polysorb braided absorbable suture gu-46 (covidien, mansfield, ma, usa).The soft tissues were approximated using 4-0 monocryl (ethicon, inc., somerville,nj, usa) suture in an interrupted manner.The skin was closed with the same suture materials by subcuticular suturing.A clear adhesive bandage was applied at the end (dermabond mini, ethicon, inc., somerville, nj, usa).The most common type of surgery via single-port incision was hysterectomy which accounted for 35% of all surgeries, followed by benign ovarian cystectomy, which accounted for 27%.Reported complications included n=4 urinary tract injuries, n=5 postoperative bleeding, n=1 umbilical wound infection, n=1 sigmoidovaginal fistula, n=1 vaginal vault evisceration and n=3 umbilical hernia.In conclusion,iit is undeniable that spa surgery provides a significantly higher cosmetic benefit and earlier recovery of the patients than multiport laparoscopic surgeries.Nevertheless, surgeons must acknowledge that there is a potentially increased risk of surgical-site complications such as herniation in spa surgery and that facial closure is a vital component.With the surgical techniques described in the present study, we have achieved a very low incidence rate of postoperative incisional hernia and these methods are believed to improve the surgical outcomes of future spa surgeries.

• Brand Name: ENSEAL GENERIC PRODUCT CODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 12362635
• MDR Text Key: 268042242
• Report Number: 3005075853-2021-04917
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K072177
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NSEALXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention