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U.S. Department of Health and Human Services

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

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ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); INSTRUMENT, ULTRASONIC SURGICAL Back to Search Results
Catalog Number LCSXX
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Paralysis (1997)
Event Type  Injury  
Manufacturer Narrative
(b)(4).Batch # unk.The lot/batch was not provided; therefore, the manufacturing records could not be reviewed.
 
Event Description
Title : comparison of minimally invasive techniques in tongue base surgery in patients with obstructive sleep apnea.Author : mehmet ali babademez, md1, mehmet yorubulut, md2, muge fethiye yurekli, md1, emre gunbey, md1, selcan baysal, md1, baran acar, md1, and riza murat karas¸ en, md1 citation: otolaryngology¿head and neck surgery 145(5) 858¿864; doi: 10.1177/0194599811414793.The aim of this prospective, randomized study was to compare the effectiveness and morbidity of 3 microinvasive tongue base surgical procedures combined with uvulopalatopharyngoplasty (uppp) in supine-dependent obstructive sleep apnea (osa) patients.Between november 2009 and may 2010, 45 patients (male=40, female=15; mean age 48.2 ± 7.1 years, age range 41-60 years) underwent uppp in which the patients were divided in 3 groups; 15 patients were in low-temperature bipolar radiofrequency (ltbr) group, 15 patients were in submucosal minimally invasive lingual excision with radiofrequency (smile-r) group and 15 patients were in submucosal minimally invasive lingual excision with a harmonic scalpel (smile-h) group.During the procedure, eight 3-cm submucosal tunnels were created, beginning from the anterior through the vallecula in the midline of the posterior one third of the tongue using the ultracision harmonic scalpel (ethicon) hand probe.These tunnels were then joined using the harmonic scalpel again, and tissue ablation was performed in the tongue base.Reported complication in smile-h group included hemorrhage approximately 100 cc of which requiring bleeding control.The same patient experienced hypoglossal nerve paralysis due to edema, and speech impairment occurred in the postoperative period.The paralysis healed completely in 3 weeks with steroid therapy.In conclusion, when the polysomnography findings and mri were evaluated, uppp + smile-r were found to be more effective.No significant difference was found between the 3 techniques when morbidity and complications were compared.
 
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Brand Name
HARMONIC SCALPEL CURVED SHEAR (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
milton garrett
475 calle c
guaynabo 00969
5133378865
MDR Report Key9288419
MDR Text Key165421032
Report Number3005075853-2019-23289
Device Sequence Number1
Product Code GEI
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
GEI
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 10/09/2019
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 NumberLCSXX
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/09/2019
Initial Date FDA Received11/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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