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

Catalog Number ACEXXX

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2012.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 : robotic major liver resections analysis of technique and intraoperative hemodynamics.Author : david calatayud, md phd, stefano d¿ugo, md, francesco coratti, md, paolo raimondi, md, federico gheza, md, mario masrur, md, enrique f elli, md, francesco m bianco, md, subashini ayloo, md, pier c giulianotti, md facs.Citation: surg endosc (2012) 26:s249¿s430.Doi 10.1007/s00464-012-2203-x.The objective of this study was to present a series of major liver resections performed by the robotic approach, focusing in the intraoperative data concerning the technical surgical aspects, as well as the hemodynamic management.There were 47 patients (male/female: 24/23) who underwent major liver resections from november 2003 to july 2011 performed in 3 different centers.The mean age of the patients was 57.01 ± 14.98 (sd), with a mean bmi of 27.63 kg/m2 ± 6.8.The harmonic scalpel was the device most frequently used during the parenchymal transection (95.7% of the cases).Postoperative bile leak was reported in 1 patient and was treated endoscopically with an ercp.In conclusion, the authors reported that robot assisted major liver resections seem to be feasible and to have good outcomes.The robotic technology could expand the role of the minimally invasive approach in hepatobiliary surgery.

• 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: 9652623
• MDR Text Key: 190648191
• Report Number: 3005075853-2020-00638
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• 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: 01/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention