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

Catalog Number	HARXX
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abscess (1690); Hematoma (1884); Inflammation (1932); Pleural Effusion (2010); Renal Failure (2041); Urinary Tract Infection (2120); Post Operative Wound Infection (2446); Insufficient Information (4580)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Publication year of 2020.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 or Problem Description
Title: laparoscopic liver resection for intrahepatic cholangiocarcinoma: a single-center experience authors: philipp konstantin haber, md, simon wabitsch, md, anika ka¨ stner, andreas andreou, md, felix krenzien, md, wenzel scho¨ ning, md, johann pratschke, md, phd, and moritz schmelzle, md citation: journal of laparoendoscopic & advanced surgical techniques volume 30, number 12, 2020 mary ann liebert, inc.Doi: 10.1089/lap.2020.0215 the aim of this study was to validate the hypothesis that laparoscopy is feasible in patients with intrahepatic cholangiocarcinoma (icc) and can elicit noninferior outcomes compared with open surgery.Clinical courses of all consecutive patients from january 2015 to october 2019 who underwent liver resection owing to icc at the department of surgery, charite´¿ universita¨tsmedizin berlin, germany were analyzed in this study.A total of 159 liver resections for icc were performed at our center, 37 of which underwent llr and 122 olr.A total of 101 patients met at least one exclusion criteria and were eliminated from further analysis.The remaining 58 patients undergoing either open (n = 31) or laparoscopic resection (n = 27) for icc were included in the study.Both for open and laparoscopic liver resection, routine intraoperative ultrasound was performed repeatedly to ensure sufficient tumor-free resection margins and rule out further intrahepatic lesions.Dissection of the parenchyma was performed in llr using harmonic ace (ethicon, somerville, nj), and vascular staplers echelon flex endopath (ethicon).Reported complications reported hematoma (n=2), renal failure (n=1), urinary tract infection (n=1), wound infection (n=8), pleural effusion (n=2), ascites (n=1), cholangitis (n=3), bile leak (n=3), intra-abdominal abscess (n=2), ileus (n=1), one patient died due to posthepatectomy liver failure.In conclusion report on one of the largest series of laparoscopically resected icc, with a high proportion of major resections.Our data show laparoscopic resection to achieve noninferior outcomes to open resection despite impaired preoperative liver function.

• Brand Name: HARMONIC ACE 5MM SHEAR
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• MDR Report Key: 12251899
• Report Number: 3005075853-2021-04262
• Device Sequence Number: 4295773
• Product Code: LFL
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: HARXX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/30/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention