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 Erosion (1750); Fever (1858); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Nerve Damage (1979); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Date 05/22/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent: 2/29/2024 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: comparison of laparoscopic sacrocolpopexy and vaginal sacrospinous ligament fixation techniques applied concomitantly in patients undergoing vaginal or laparoscopic hysterectomy for uterovaginal pelvic prolapse author: ömer ünal1,, ozan karadeniz citation: https://doi.Org/10.31083/j.Ceog5005110 the aim of this study was to investigate patients having pelvic organ prolapse (pop) stage 2 and greater who have undergone vaginal hysterectomy concomitant with sacrospinous ligament fixation (vah + slf) or total laparoscopic hysterectomy concomitant with sacrocolpopexy (tlh + scp) in terms of quality of life, sexual function, major or minor complications, and cure rates.We also aimed to determine which procedure is superior according to the results of the cases in which tlh + scp and vah + slf were applied.A retrospective cohort study was conducted at a tertiary center, including 137 patients who underwent vaginal or laparoscopic hysterectomy for symptomatic uterine prolapse with a pelvic organ prolapse quantification system (pop-q) score=2 and who underwent sacrospinous fixation (n = 90) or laparoscopic sacrocolpopexy (n = 47) concomitantly between january 2017 and may 2022.Harmonic device (hp300 ethicon) was used to cut the peritoneum; 0 prolene suture (ethicon) was used during the sacrospinosus ligament fixation procedure; lastly, 2/0 vicryl suture (ethicon) was used to repair the rectovaginal fascia.Reported complications are postoperative fever, vaginal cuff coagulum, vaginal cuff infection, urinary tract infection, mesh or suture erosion, neural entrapment, ileus, bladder injury, bleeding, bowel injury and intra-abdominal hematoma.In conclusion, the tlh + scp group had the same decrease in subjective outcomes (pisq-12 and p-qol), whereas the vah + slf group had a lower major complication rate than the tlh + scp group.There is a need for a prospective, multicenter, randomized controlled study with multiple patients and long-term follow-up results to understand the ideal form of vaginal cuff suspension following a hysterectomy.

• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 18807175
• MDR Text Key: 336554356
• Report Number: 3005075853-2024-01741
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• 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: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention