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 Problems Pulmonary Embolism (1498); Adult Respiratory Distress Syndrome (1696); Fistula (1862); Hematoma (1884); Inflammation (1932); Pleural Effusion (2010); Pneumonia (2011); Blood Loss (2597); Bowel Perforation (2668); No Code Available (3191)

Event Date 01/01/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Date of event: publication year of 2013.Batch # unk.This report is related to a journal article, therefore no product will be returned for analysis and the device history records cannot be reviewed as the lot/batch number has not been provided.(b)(4).

Event Description

It was reported via literature entitled: risk factors and management of conversions to an open approach in laparoscopic liver resection: analysis of 265 consecutive cases authors: roberto i.Troisi, roberto montalti, jurgen g.M.Van limmen, daniele cavaniglia, koen reyntjens, xavier rogiers and bernard de hemptinne.Citation: hpb 2014, 16, 75¿82; doi:10.1111/hpb.12077.This study aimed to identify predictive factors of conversion to an open approach on 265 laparoscopic liver resections performed over an 8-year period, focusing on causes of conversion, technical issues and outcomes.Between january 2004 and december 2011, 265 liver resections (age 55.7 ± 16 years) were performed by laparoscopy.Parenchymal division was almost exclusively performed using a surgical aspirator and the harmonic scalpel (ultracision; ethicon endosurgery, cleveland, oh, usa) for the glissonian approach.Larger vascular and biliary structures were controlled with endoclips (hem-o-lock clips) or vascular staplers (endogia; ethicon).Complications included biliary fistulae (n=4), pneumonia (n=5), ileus (n=4), biliary leak (n=4), ascites (n=4), bleeding (n=3), pleural effusion (n=3), fluid collections (n=2), lung embolism (n=1), wound hematoma (n=1), pancreatitis (n=1), cholangitis (n=1), acute respiratory distress syndrome (ards) (n=1), bowel perforation (n=1), stapler failure (n=1).In conclusion, llr can be safely performed with low overall morbidity.According to this experience and irrespective of the learning curve, resections of p-s segments were identified as an independent risk factor for conversion in llr.

• 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 ; * 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: 9674187
• MDR Text Key: 191262453
• Report Number: 3005075853-2020-00786
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• 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: 01/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention