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

Catalog Number HARXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pulmonary Embolism (1498); Pneumonia (2011); Pneumothorax (2012); Blood Loss (2597); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Publication year of 2019.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.

Event Description

Title: prospective, multicenter, international phase 2 trial evaluating ultrasonic energy for pulmonary artery branch sealing in video-assisted thoracoscopic surgery lobectomy.Authors: moishe liberman, md, phd; eric goudie, md; christopher morse, md; wael hanna, md, mba; nathaniel evans, md; kazuhiro yasufuku, md, phd; john sampalis, phd.Citation: doi: https://doi.Org/10.1016/j.Jtcvs.2019.09.061.This prospective, multicenter, international phase 2 study objectives were to evaluate the immediate, short, and medium-term efficacy and safety of pulmonary artery branch sealing using an ultrasonic vessel-sealing device in minimally invasive anatomic lung resection.A total of 150 patients (age range: 33 to 82 years old; 93 female and 57 male patients) with a minimum of 1 pulmonary artery branch sealed with an ultrasonic vessel-sealing device were prospectively enrolled in the trial.The harmonic ace+7 shears with advanced hemostasis (ethicon) was the ultrasonic energy vessel-sealing device evaluated in this trial.Surgeons were instructed to perform the planned anatomic lung resection following their standard technique except for pa division.Division and sealing of the lobar and segmental pa branches 7 mm or less in diameter were performed with the harmonic ace+7 shears with advanced hemostasis (ethicon).Pa vessels with diameters 1 to 5 mm were sealed on the minimum setting with generator set at level ¿¿3¿¿, and vessels between 5 and 7 mm were sealed using the advanced hemostasis setting.The harmonic ace+7 shears with advanced hemostasis (ethicon) was used in both vats and rats approaches with the same technique for pa sealing.Reported complications included seal failure after sealing with the ace+7 device (n-3) in which in 1 case, the branch had sealed initially; however, the corner of the stump started bleeding at the end of the operation because of suction trauma.A clip was applied on the pa stump to control the bleeding.The second bleed related to the ace+7 was on a 5-mm anterior pa branch during a right upper lobectomy.The bleeding was difficult to control during thoracoscopy; therefore, conversion to thoracotomy was necessary to allow for suture of the pa stump that controlled the bleeding.The third bleed with ultrasonic sealing was on a 6-mm anterior basal artery during a left lower lobectomy.The bleeding was coming from the corner of the pa stump immediately after the energy device was applied and necessitated a single clip placement; bleeding from a bronchial artery (n-1) which required reoperation; prolonged air leak (n-23); pneumonia (n-9); pneumothorax (n-4); pulmonary embolism (n-1).Pa branch sealing with an ultrasonic energy device during vats lobectomy is safe for vessels 7 mm or less.There was no difference in bleeding between ultrasonic-sealed vessels and vessels sealed with endostaplers.The use of an ultrasonic device is a reasonable sealing method for small pa branches.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; * 00969 ; 6107428552
• MDR Report Key: 10556814
• MDR Text Key: 215643123
• Report Number: 3005075853-2020-04757
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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: 08/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention