MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. LIGACLIP EXTRA TITANIUM CLIPS; CLIP, IMPLANTABLE

Catalog Number LTXXX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Publication year of 2019.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. .

Event Description

It was reported that during review of a journal article, title: the use of plasmakinetic cautery compared to conventional electrocautery for dissection of abdominal free flap for breast reconstruction: single-centre, randomized controlled study.Author : whitney t.H.Chow, georgette oni, venkat v.Ramakrishnan, mat griffiths.Citation: gland surg 2019;8(3):242-248; doi: 10.21037/gs.2018.12.04.This prospective randomized blinded study aimed to investigate whether the use of the plasmakinetic cautery confers clinical benefits over conventional electrocautery diathermy in abdominal flap dissection during breast reconstruction.From january 2014 to november 2014, a total of 40 patients were blindly randomized to either ¿group 1- conventional electrocautery¿ (n=20, mean age: 55 years, mean bmi: 29 kg/m2) or ¿group 2-plasmakinetic cautery¿ (n=20, mean age: 54 years, mean bmi 27.9 kg/m2) with the ratio of 1:1, for the dissection of the abdominal free flap.During surgery, bleeding vessels were cauterized except for large perforating branches, which were clipped with ligaclips (ethicon).Vicryl mesh (ethicon) was routinely placed under the rectus sheath on closure.The closure of the abdominal wound in layers with 3/0 vircyl (ethicon) to the fascia, stratafix barbed sutures (ethicon) to dermis and dermbond topical skin adhesive (ethicon) for wound final approximation.Complaints included seroma formation (n=27) where 4, 14 and 9 seromas were detected at days 7, 14 and 42 post-operation respectively and only one seroma required drainage during their outpatient visit at 14 days post-operation.Other complaints are hematoma (n=3) which required further surgery to evacuate the hematoma, and suspected wound infection (n=1) who need antibiotics post-discharge.In conclusion, this study demonstrates that there are no significant differences between the use of plasmakinetic cautery and conventional electrocautery for abdominal free flap dissection.

• Brand Name: LIGACLIP EXTRA TITANIUM CLIPS
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• Manufacturer Contact: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9491045
• MDR Text Key: 188815262
• Report Number: 3005075853-2019-24547
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LTXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention