MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC AQUAMANTYS ENDO DBS 8.7; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 23-317-1

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

Patient Problems Reaction (2414); Blood Loss (2597)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Title of article: efficacy of laparoscopic saline-coupled bipolar sealer in minimally invasive hepatobiliary surgery.Authors: amit sastry, md, jesse k.Sulzer, phd, md, michael passeri, md, erin h.Baker, md, dionisios vrochides, md, facs , iain h.Mckillop, phd , david a.Iannitti, md, facs, and john b.Martinie, md, facs abstract: hepatic resection presents unique surgical challenges to reduce blood loss during parenchymal division.The development of saline-coupled bipolar devices, in which hemostasis is achieved at lower temperatures than electrocautery or other bipolar sealing devices, have been employed for open hepatic resection.Saline-coupled bipolar devices have now become available for minimally invasive use.The goals of this study were to evaluate the feasibility and safety of a laparoscopic saline-coupled bipolar device for minimally invasive hepatectomy.Seventeen patients (median age 66 years, range 36-81) were consented for inclusion and enrolled.Patient demographics, intraoperative data, and surgeon feedback were collected.Seven robot-assisted partial hepatectomies, 9 laparoscopic partial hepatectomies, and 1 laparoscopic cholecystectomy with liver abscess resection were performed.Average operating time was 222 ± 33 minutes (median 188 minutes; range 61-564 minutes) with no difference between robotic versus laparoscopic time.Successful seals were achieved in all cases following application of 150 to 200 j energy (average 179 ± 3 j, average time to achieve a successful seal 9.3 ± 2.7 minutes).There were no perceived malfunctions during the study period.Adverse events: estimated blood loss was 362 ± 74 ml (median 300 ml, range 5-1200 ml) and 3/17 patients received intraoperative blood transfusion.No bile leaks were detected in any of the patients.Median length of stay was 5 days (range 1-20 days), and there were no readmissions within 30 days.Postoperative morbidity occurred in 5/17 patients, all of which were clavien grade 1.Adverse events of related studies referenced in article: 6 of 170 patient received blood transfusions.4 of 170 patient had transient bile leaks, 3 of which resolved spontaneously, and one required an endoscopic retrograde cholangiopancreatography.

• Brand Name: AQUAMANTYS ENDO DBS 8.7
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee bosivert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 8856115
• MDR Text Key: 153136850
• Report Number: 1226420-2019-00130
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123201
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 23-317-1
• Device Catalogue Number: 23-317-1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention