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

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.

• 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 Key: 9288419
• MDR Text Key: 165421032
• Report Number: 3005075853-2019-23289
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: GEI
• 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: 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 Number: LCSXX
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention