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 Necrosis (1971)

Event Date 01/01/2011

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date of event: publication year of 2011.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: comparison of uae and laparoscopic uterine artery occlusion (luao) for fibroids: the results of non-randomized clinical trial.Authors: kubinova k.; mara m.; maskova j.; novotna m.; kuzel d.Citation: journal of minimally invasive gynecology.Conference: 40th global congress of minimally invasive gynecology, aagl 2011.Hollywood, fl united states.Conference publication: (var.Pagings).18 (6 suppl.1) (pp s72), 2011.Date of publication: november-december 2011.The objective of this prospective study was to compare the results of surgical and radiological occlusive therapy of uterine fibroids.A total of 183 female patients (98 uae and 85 luao patients) under the age of 40 with intramural fibroid/s larger than 3cm were included in the study.Embosphere was used in uae while the harmonic scalpel was utilized in luao.Mean follow up was longer (40 vs.27 months) in patients with uae.A significantly lower complete myoma infarction (p<0.0001) was noted after luao (35%) compared with uae (82%).Mean shrinkage of dominant fibroid volume (on mri) was significantly lower (p<0.001) after luao (42%) compared with uae (55%).The authors concluded that uae is more effective than luao in causing complete ischemia and larger shrinkage of dominant fibroid.But uae-caused necrosis of fibroids can seriously impair uterine cavity, which may lead to infertility and abortions.

• 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: 9491673
• MDR Text Key: 188788733
• Report Number: 3005075853-2019-24544
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 12/18/2019
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1