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

Catalog Number HARXX

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Event date unk.Batch # unk.As the device was not returned, an analysis investigation could not be performed.A conclusion could not be reached as to what may have caused or contributed to the event.Complaint information is trended on a regular basis to determine if further investigation is warranted.We did not receive a batch or lot number for the product involved in this complaint.Therefore, we were unable to check manufacturing records for any related non-conformance.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 surgeon/author believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.

Event Description

It was reported via journal article title: primary spontaneous pneumothorax: simultaneous treatment by bilateral non-intubated videothoracoscopy.Author : zhihua guo, weiqiang yin, xin zhanga,b,c, xin xu, hui liud, wenlong shao, jun liu, hanzhang chen and jianxing he.Citation: interactive cardiovascular and thoracic surgery 23 (2016) 196¿201.Doi:10.1093/icvts/ivw123.The authors assessed the feasibility and safety of simultaneous bilateral thoracoscopic wedge resection of blebs or bullae for the treatment of primary spontaneous pneumothorax (psp) under thoracic epidural anaesthesia with spontaneous ventilation.This retrospective study involves 37 patients who underwent simultaneous bilateral thoracoscopic wedge resection of blebs or bullae for the treatment of primary spontaneous pneumothorax (psp) between july 2011 and september 2015.The patients were divided into 2 groups: in non-intubated group, 22 patients (21 male and 1 female; mean age: 26.2 ± 11.4, bmi: 18.9 ± 2.3) was under intubated general anaesthesia and in intubated group, 15 patients (14 male and 1 female; mean age: 21.9 ± 5.2 years; bmi: 18.6 ± 2.7) was under spontaneous ventilation thoracic epidural anaesthesia.During the procedure, pleural adhesions were completely freed using electrocautery or endoscopic harmonic scalpel (ethicon) under video vision.Lung blebs or bullae were resected using an endostapler (echelon 45 endopath stapler; ethicon).When no blebs or bullae were visible, a small portion of the apex of the lung was routinely resected.Reported complications in the non-intubated group included recurrence (n-1), and in intubated group included air leak > 5 days (n-2), and recurrence (n-1).In conclusion, simultaneous bilateral thoracoscopic wedge resection of blebs or bullae utilizing non-intubated anaesthesia is safe, feasible and well tolerated.This technique is a simple and valid alternative to conventional intubated general anaesthesia for the surgical management of selected patients with simultaneous bilateral psp or with high risk of contralateral recurrence.

Manufacturer Narrative

Product complaint # (b)(4).Date sent(b)(6)2020.H1: mdr decision: not reportable upon review of the information provided, it was concluded that this event does not meet the fda defined criteria for a reportable event and is being considered not reportable.Additional information was requested, and the following was obtained: does the surgeon/author believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.The author does not believe that the ethicon device caused the patient complications mentioned in the article.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969
• MDR Report Key: 9652802
• MDR Text Key: 190132997
• Report Number: 3005075853-2020-00648
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K120729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 03/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention