MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number ACEXXX

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

Patient Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2015.Medical device: 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.

Event Description

Title : a conceptual technique for laparoscopic right hepatectomy based on facts and oncologic principles.Author : olivier soubrane, md, lilian schwarz, md, franc¸ois cauchy, md, laura ornella perotto, md, raffaele brustia, md, denis bernard, md,¿ and olivier scatton, md, phd.Citation: ann surg 2015;261:1226¿1231; doi: 10.1097/sla.0000000000000737.This study aimed to evaluate a new conceptual technique of laparoscopic right hepatectomy.Between oct2011 and sep2013, 30 patients (n=18 male and n=12 female; mean age of 67 years [29-84 years]; mean bmi of 24 kg/m^2 [17-35 kg/m^2]) underwent laparoscopic right hepatectomy for malignant disease (n=24), benign lesions (n=4) and living donation (n=2).In the procedure, the liver capsule was opened with harmonic scalpel.The parenchyma was divided starting from the bottom using an ultrasonic dissector together with bipolar cautery or harmonic scalpel for small vessels of 3 mm or less.After completing parenchyma transection up along the ivc, the right hepatic vein is reached, dissected free, and stapled with a vascular stapler.Intraoperative complications included two patients who had hemorrhage.The first patient was a (b)(6)-year-old with hepatocellular carcinoma who had bleeding from the segment 5 vein and median hepatic vein that could not be controlled through laparoscopy, requiring blood transfusion and conversion to laparotomy through a hybrid technique with limited midline incision.The second patient was a (b)(6)-year old with hepatocholangiocarcinoma who had bleeding from the inferior right hepatic vein during a long and difficult liver parenchyma transection due to hypertrophy of segment iv after portal vein embolization, requiring blood transfusion and eventually the patient was converted to laparotomy through a hybrid technique with complete j-shaped subcostal incision.Postoperative complication included one patient with peritonitis due to ileal perforation requiring reoperation.This study showed that several evidence-based facts could be combined to define a new conceptual technique of laparoscopic right hepatectomy allowing for low blood loss and morbidity.

• Brand Name: ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN)
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: 9508553
• MDR Text Key: 188997680
• Report Number: 3005075853-2019-24722
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051036
• 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: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention