MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN); ULTRACISION * SURG DEV, SHEARS, ENDOSCOPIC

Catalog Number LCSXX

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Nerve Damage (1979)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: (b)(6) 2022.Publication year of 2018.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.Additional information was requested and the following was obtained: does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.Contact the reporter via phone on (b)(6) 2022, no information can be provided currently.Once there is any update, we will update the information.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

Title: transoral surgery in large thyroid gland use in benign tumors * authors: peng wen 1 peng xiaowei 1 li zan 1 li hui 1 zhou xiao 1 song dajiang 1 zhou bo 1 lv chunliu 1 wu peng 1 ouyan 1 citation: journal of clinical otorhinolaryngology head and neck surgery (2018);32(13):972-975.Doi: 10.13201/j.Issn.10011781.2-018.13.003 the aim of this study is to investigate the value and feasibility of transoral thyroid surgery in the treatment of benign thyroid tumors.From july 2016 to december 2017, a total of 76 patients with benign thyroid tumor who met the criteria were treated surgically.Among them, 31 cases (3 male and 28 female; age was 34±10 years) were treated with thyroid surgery via oral vestibular approach (endoscope group) using harmonic scalpel and 4-0 absorbable suture (johnson & johnson vcp771d), and 45 cases (9 male and 36 female; age was 36±9 years) were treated with traditional open surgery at the same time.Reported complications include temporary recurrent laryngeal nerve injury (n=1) and recovered after 3 months.In conclusion, transoral thyroid surgery is safe and effective in the treatment of benign thyroid masses, and is a good choice for patients with cosmetic needs.

• Brand Name: HARMONIC SCALPEL CURVED SHEAR (EXACT CODE UNKNOWN)
• Type of Device: ULTRACISION * SURG DEV, SHEARS, ENDOSCOPIC
• Manufacturer (Section D): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer (Section G): ETHICON ENDO-SURGERY, LLC.; 475 calle c; guaynabo 00969 ; * 00969
• Manufacturer Contact: orla o'mahony ; 475 calle c; guaynabo ; * ; 329348013
• MDR Report Key: 15310055
• MDR Text Key: 298773090
• Report Number: 3005075853-2022-05624
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• 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
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other