MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGAMAX-5MM ENDO CLIP APPLIER; CLIP, IMPLANTABLE

Model Number EL5ML

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Hematoma (1884); Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 08/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: date of publication is (b)(6) 2021.This report is related to a journal article; therefore, no product will be returned for analysis.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that during a journal article review: title: uterine artery closure at the origin versus at the uterus level in total laparoscopic hysterectomy: a randomized controlled trial authors: stefano uccella, simone garzon, gabriele lanzo1, davide gallina, mariachiara bosco, irene porcari, salvatore gueli-alletti, stefano cianci, massimo franchi, pier carlo zorzato.Citation:acta obstet gynecol scand.2021;00:1¿9.Doi: 10.1111/aogs.14238 https://doi.Org/10.1111/aogs.14238.This study is a single-blind, parallel groups, two-arm, randomized controlled trial.The trial was conducted at the division of obstetrics and gynecology, department of maternal, neonatal and infant health, asl biella, biella, italy.Patient recruitment began on december 1, 2019 and ended on august 31, 2020.All surgeons perform hysterectomy using the same laparoscopic technique, which is standardized at the center in terms of instruments, steps, colpotomy, and colporrhaphy.A 30-day follow-up visit was performed for 172 patients (95.5%).The eight patients who did not attend the 30-day follow-up visit had a phone follow up.All 180 women were contacted by phone 4 months after surgery and completed the follow up.The ureter was visualized and followed along its course.With the opening of pararectal and paravesical spaces, the ua and its origin were identified and reached.The vessel was clipped just medially to its origin from the internal iliac artery using 5-mm titanium clips (ligamax¿5 endoscopic multiple clip applier,ethicon).Reported complications included intraoperative blood loss was higher in uterus level group (ul group) and bladder lesions , postoperative infection (n=3), vaginal cuff dehiscence (n=1), postoperative vaginal bleeding (n=3), vaginal evisceration (n=1), vaginal cuff hematoma/abscess(n=4) in conclusion the ua closure at the origin is superior to the closure at the ul in terms of lower intraoperative blood loss and higher reproducibility.However, the absence of translation into clinical benefits impedes the support of its clinical superiority in all cases.The routine uses of this approach may provide advantages in specific conditions, such as in the presence of severe preoperative anemia, deep infiltrating endometriosis, or ureteral duplication.Further studies should investigate whether ua closure at the origin reduces or increase complication rates, such as vaginal cuff complications, and further characterized clinical benefits.

• Brand Name: LIGAMAX-5MM ENDO CLIP APPLIER
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo ; *
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo ; * ; 6107428552
• MDR Report Key: 12564446
• MDR Text Key: 274421394
• Report Number: 3005075853-2021-05874
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 10705036001843
• UDI-Public: 10705036001843
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050344
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: EL5ML
• Device Catalogue Number: EL5ML
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2021
• Initial Date FDA Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention