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

Catalog Number HARXX

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Wound Dehiscence (1154); Abortion (1688); Headache (1880); Hemorrhage/Bleeding (1888); Impaired Healing (2378); Numbness (2415); Fluid Discharge (2686); Syncope/Fainting (4411); Unspecified Tissue Injury (4559); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/17/2021

Event Type  Injury  

Event Description

Title: operative and obstetric outcomes after single-port laparoscopic myomectomy: a retrospective single-center analysis of 504 cases.Authors: yeon hee hong, md, eunjin song, md, seul ki kim, md, jung ryeol lee, md, phd, and chang suk suh.Citation cite: https://doi.Org/10.1016/j.Jmig.2021.06.011.The objective of this study is to analyze the obstetric and operative outcomes of 504 cases of single-port laparoscopic myomectomy (splm).It is a single-center retrospective study with a total of 502 patients (504 splm procedures) who underwent splm for symptom relief or growing myomas between october 2009 and april 2020.The mean age of the patients was 40.6 + 6.6 years.The patients had an average of 2.3 + 2.2 myomas removed; the largest myoma size was 6.8 + 2.4 cm.A myometrial incision was then made vertically, using a monopolar or ultrasonic device (harmonic scalpel; ethicon endo-surgery, cincinnati, oh), until the myoma surface was visible.After removing the myoma(s), the myometrium was repaired with interrupted intracorporeal absorbable sutures (vicryl; ethicon endo-surgery, cincinnati, oh).Enucleated myomas were extracted using an electromechanical morcellator (x-tract; ethicon endo-surgery, cincinnati,oh).After irrigation, an adhesion barrier (interceed; ethicon endo-surgery, cincinnati, oh) was applied at the myomectomy site.The fascia and peritoneum were sutured using 2-0 vicryl sutures (ethicon endo-surgery, (b)(4)) and the skin was closed using 4-0 vicryl sutures (ethicon endo-surgery, (b)(4)).Reported complications included intraoperative complication loss of blood and bowel injury (n=4).Postoperative complications: blood loss (n=16), wound complication (serous discharge, minor dehiscence, maladaptive wound healing) (n=15) , headache, thigh numbness, and syncope (n=6), recurrence (n=148).Ten patients experienced obstetric complications, including uterine atony, placenta previa, preterm labor, second-trimester bleeding.Aborted pregnancies (n=2).In conclusion we observed in this study that splm was feasible and safe for treating symptomatic or growing myomas and that it was associated with satisfactory obstetric outcomes.Therefore, splm is a safe and effective option for women who require surgical treatment for myomas but wish to preserve their fertility.

Manufacturer Narrative

(b)(4).Event date: publication year of 2021.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.

• 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: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15039960
• MDR Text Key: 296047367
• Report Number: 3005075853-2022-04637
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K120729
• 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: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2022
• 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
• Date Manufacturer Received: 06/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention