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

Catalog Number HARXX

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

Patient Problems Unspecified Infection (1930); Ischemia (1942); Blood Loss (2597); Bowel Perforation (2668); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2016.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: learning curve for laparoscopic major hepatectomy: use of the cumulative sum method author/s: fiona ka-man chan, kai-chi cheng, yuk-pang yeung and kit-man ho citation: surg laparosc endosc percutan tech 2016;26:e41¿e45 this study aimed to investigate the feasibility and safety of lmrs by learning curve analysis.A total of 151 patients underwent 156 llrs from 2002 to 2014.There were 49 major hepatectomies (median age 65 years, male n=37, female n=12) and 107 minor hepatectomies (median age years, male n=71 and female n=36).Five ports were used and placed according to tumor location.Parenchymal dissection was performed by cavitron ultrasonic surgical aspirator (valleylab inc., boulder, co), harmonic scalpel (harmonic ace; ethicon endosurgery, johnson & johnson, langhorne, pa), or ligasure (valleylab).Complications included failed dissection of pedicle (n=3) and bleeding (n=4) which lead to conversion to open surgery.Further complications included bile leak (n=7), three were managed conservatively, 2 required endobiliary and image-guided drainage, and 2 required relaparotomy: one patient after laparoscopic assisted left hepatectomy required laparotomy for control of bile leak from segmental ducts and t-tube for drainage; the second was the result of duodenal perforation (n=1) requiring patch repair; infected ascites (n=1) which required relaparotomy and extensive bowel ischemia (n=1) requiring reoperation and resulted in mortality.In conclusion, laparoscopic major resection is safe and feasible; operative outcomes improved after overcoming the learning curve.

Manufacturer Narrative

(b)(4).Date sent: (b)(6)2020.H10: corrected data = h1 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 believe the ethicon harmonic device caused or contributed to the patient¿s post-operative issues to include the patient death? if so, why or why not? no.Actually we were using the harmonic scalpel ace + 7 in a swinging maneuver and it's especially useful for macronodular cirrhotic liver, which other energy device cannot provide the same result.

• 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: 9629804
• MDR Text Key: 184932086
• Report Number: 3005075853-2020-00549
• 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
• Type of Report: Initial,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• 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: 01/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention