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

Catalog Number HARXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240); Post Operative Wound Infection (2446); Neuralgia (4413)

Event Date 12/05/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.What were the specific number of patients who had postoperative pain in group a and group b at 1 day after surgery, prior to discharge, at 1 week, 2 weeks, 1 month, and 6 month after surgery? 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: comparison of mesh fixation and nonfixation in laparoscopic transabdominal preperitoneal repair of inguinal hernia.Authors: behrooz kalidarei, mohsen mahmoodieh, zakaria sharbu citation: formosan journal of surgery.2019; 52 (6): 212-220.Doi: 10.4103/fjs.Fjs_15_19.The aim of this present randomized clinical trial was to evaluate the incidence rate of complications such as urinary retention, seroma, wound infection, and recurrence of hernia, after applying two methods of fixed and nonfixed tapp in an iranian population during 6 months after operation.In addition, this study evaluated the patients pain level and made attempts to report more accurate results by distinguishing the direct and indirect types of hernia.Between april 2017 to march 2018, a total of 80 patients with inguinal hernia underwent tapp laparoscopy with mesh fixation (n = 41; 31 male and 10 female; mean age = 50.51 ¿ 10.23 years) and nonfixation (n = 39; 32 male and 7 female; mean age = 53.87 ¿ 8.37 years) in (b)(6).Surgery was performed in both groups using a harmonic scalpel (ethicon) and a 10 cm ¿ 15 cm-mesh (prolene mesh; ethicon).Mesh was fixed using a competitor suture or spiral tacks in group a and nonfixed in group b.Continuous absorbable sutures (vicryl 3/0; ethicon) were used to close the peritoneum in both groups.Reported complications included seroma (n=5); wound infection (n=2); urinary retention (n=19); neuralgia (n=12); hernial recurrence (n=2); postoperative pain score of 3.61¿2.35 at 1 day after surgery (n=?); postoperative pain score of 3.00¿2.22 at 1 day after surgery (n=?); postoperative pain score of 3.34¿2.26 prior to discharge (n=?); postoperative pain score of 2.03¿2.18 prior to discharge (n=?); postoperative pain score of 2.76¿1.62 at 1 week after surgery (n=?); postoperative pain score of 1.74¿1.50 at 1 week after surgery (n=?); postoperative pain score of 1.41¿1.29 at 2 weeks after surgery (n=?); postoperative pain score of 2.34¿1.37 at 2 weeks after surgery (n=?); postoperative pain score of 1.32¿1.47 at 1 month after surgery (n=?); postoperative pain score of 1.00¿0.92 at 1 month after surgery (n=?); postoperative pain score of 0.66¿1.17 at 6 months after surgery (n=?); and postoperative pain score of 0.26¿0.59 at 6 months after surgery (n=?).In conclusion, mesh nonfixation causes less postoperative complications and pain in patients undergoing tapp repair; however, in long-term follow-up, the level of chronic pain following the application of mesh fixation and non-fixation methods is not different.

• 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 ; * ; 6107428552
• MDR Report Key: 11697008
• MDR Text Key: 247061313
• Report Number: 3005075853-2021-02135
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: IR
• 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: 03/25/2021

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 Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention