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 Fever (1858); Unspecified Infection (1930); Perforation of Esophagus (2399); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Batch # unk.Date of event is unknown.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.

Event Description

It was reported that during review of journal article, title: endoscopic thyroidectomy using a new bilateral axillo-breast approach author(s): jun-ho choe, md, seok won kim, md,2 ki-wook chung, md,2 kyoung sik park, md, 1 wonshik han, md,1 dong-young noh, md,1 seung keun oh, md,1 yeo-kyu youn, md citation: world j surg (2007) 31: 601¿606; doi: 10.1007/s00268-006-0481-y.This study aimed to evaluate the feasibility of bilateral axillo-breast approach (baba) and the completeness of total thyroidectomy using this approach.From jul 2001 to nov 2005, 135 patients (n=133 females and n=2 males; mean age of 36.9 years [ranging from 20 to 56 years]) underwent endoscopic thyroidectomy in which the initial 25 patients had axillo-bilateral breast approach (abba) and 110 patients had baba technique.In surgical procedure for the baba, thyroidectomy was performed using harmonic scalpel under full visualization of superior and inferior thyroidal arteries, parathyroid glands and recurrent laryngeal nerves.In baba group, there was a case of tracheal perforation which required conversion to open surgery.Postoperative complications included unilateral vocal cord palsy (n=4) which resolved within 6 months, and infection (n=1).The case of postoperative infection occurred in a (b)(6) year-old woman who had initial complaints of neck swelling and fever.A ct scan revealed fluid collection around the operative field.This was responded by performing an incision and draining the pus; however, the patient¿s fever was not resolved.After 2 days of observation exploration was elected.Surprisingly, there was an esophageal perforation near the site of the superior thyroid artery ligation.It was concluded that there was a possibility of thermal injury to the esophagus during thyroid artery ligation with the harmonic scalpel.Gauze packing was maintained for 25 days and eventually her condition improved, and she was discharged.In conclusion, the baba can provide an optimal endoscopic view and enables a bilateral approach to the thyroid gland, resulting in a feasible method of total thyroidectomy.The complication rate for the procedure is low and its cosmetic outcome is superior to that of other methods.

• 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: kara ditty-bovard ; 475 calle c; guaynabo 00969 ; 6107428552
• MDR Report Key: 9440184
• MDR Text Key: 185234690
• Report Number: 3005075853-2019-24109
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: GEI
• 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: 11/12/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention