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

Catalog Number ACEXXX

Device Problem Device Handling Problem (3265)

Patient Problems Failure to Anastomose (1028); Injury (2348); Blood Loss (2597); Bowel Perforation (2668)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

The lot number is unknown.Without the specific part number; the udi number and 510-k number are unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Concomitant medical products: unknown.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Date of event: publication year of 2009.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 : electrothermal bipolar vessel sealing system vs.Harmonic scalpel in colorectal laparoscopic surgery: a prospective, randomized study.Author : roberto rimonda, m.D.& alberto arezzo, m.D.& corrado garrone, m.D.Marco ettore allaix, m.D.& giuseppe giraudo, m.D.& mario morino, m.D.Citation: dis colon rectum.2009; 52: 657y661.Doi: 10.1007/dcr.0b013e3181a0a70a.This study was designed to compare the efficacy and safety of laparoscopic colorectal surgery performed with the aid of ligasure vessel-sealing system or ultracision (ethicon).Patients eligible for elective laparoscopic right or left hemicolectomy or anterior resection of the rectum were randomly assigned to either the use of ligasure or ultracision.Between april 2005 and december 2006, a total of 140 consecutive patients were included in the study.Of which, 70 patients (49 male and 21 female patients; age: 68.1 years; bmi: 26.8) were randomized under ligasure and 70 patients (44 male and 26 female patients; age: 63.7 years; bmi: 25.4) were randomized under ultracision.During the procedure in the ultracision group, dissection was performed with ultracision (ethicon).In the ultracision group, reported complications included anastomotic leakage (n-3), anastomotic stenosis (n-1), bowel perforation (n-1), post-operative bleeding (n-1), and injury to the vaginal wall (n-1) which was observed and repaired laparoscopically.In conclusion, the study failed to demonstrate any significant advantage of the use of the ligasure device when compared with the ultracision device in laparoscopic colorectal surgery in terms of blood loss, intraoperative and postoperative morbidity, and operative time.Both devices could be of help, especially at the beginning of the surgeon¿s experience and in difficult cases.Choice between the two devices should be performed according to surgeon¿s preference.A copy of this literature article is attached to this medwatch report.

Manufacturer Narrative

Ethicon is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which ethicon has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, ethicon or its employees that the report constitutes an admission that the device, ethicon , or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• 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
• MDR Report Key: 9383200
• MDR Text Key: 168620542
• Report Number: 3005075853-2019-23805
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ACEXXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 11/27/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GENERATOR AND HANDPIECE
• Patient Outcome(s): Required Intervention