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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. ULTRACISION HARMONIC ACE (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
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.
 
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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 Key9491673
MDR Text Key188788733
Report Number3005075853-2019-24544
Device Sequence Number1
Product Code LFL
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
K051036
Number of Events Reported1
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
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberACEXXX
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/29/2019
Initial Date FDA Received12/18/2019
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 Number1
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