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 Problems Burn(s) (1757); Hemorrhage/Bleeding (1888); Nerve Damage (1979); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event: publication year for the journal article is 2010.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.This complaint has been documented based on the information available within the article; however, due to the age of the journal article, additional event details will not be pursued.

Event Description

It was reported that during review of journal article, title: minimally invasive video-assisted thyroidectomy: experience of 300 cases.Author/s: youben fan, bomin guo, shunli guo, jie kang, bo wu, pin zhang, qi zheng.Citation: surg endosc (2010) 24:2393¿2400; doi 10.1007/s00464-010-0960-y.This study aimed to summarize the safety and feasibility of minimally invasive video-assisted thyroidectomy (mivat).From february 2005 to august 2008, a total of 300 patients (n=36 male n=264 female, mean age: 54.6 years, range: 23-71 years) underwent mivat using a single central incision with an average length of 2 cm (range = 1.5¿3 cm), about 2 cm above the sternal notch.Small conventional retractors and dissectors, ultrasonic scalpel (ethicon), 5-mm laparoscope, and a video screen were the instruments used.The ultrasonic scalpel (ethicon) was used to dissect the middle thyroid vein and the upper and lower pole vessels.Also, under direct vision, the back of the thyroid lobe was dissected completely with the ultrasonic scalpel.If blood was still oozing from the residual thyroid tissues, ultrasonic scalpel or resorbable stitches were used for hemostasis.Complaints included massive hemorrhage from the vessels of the upper peduncle (n=1).This patient was converted to open surgery.Other operative complaints included permanent unilateral recurrent laryngeal nerve (rln) palsy (n=5), transient unilateral rln palsy (n=7), superior laryngeal nerve (sln) injury (n=5), transient hypoparathyroidism (n=9), and mild skin burn from the ultrasonic scalpel (n=5).In conclusion, mivat appears to be safe and feasible in patients with benign thyroid nodules, with minimal injury and excellent cosmetic results.

• 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: 9462325
• MDR Text Key: 188396173
• Report Number: 3005075853-2019-24246
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K051036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention