MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. UNK_ULTRACISION HARMONIC FOCUS

Catalog Number UNK_ULTRACISION HARMONIC FOCUS

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Nerve Damage (1979); Speech Disorder (4415); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/01/2017

Event Type  Injury  

Event Description

Title: comparative study of focus harmonic scalpel and electrosurgical knife in thyroid benign tumor surgery.Authors: xiang deyu, qin zhanglu, zhou xingjian, hu kan, guo chaoyang.Citation: journal of gannan medical college (aug-2017); 37 (4).Doi: 10.3969/j.Issn.1001-5779.2017.04.008.The aim of this retrospective study is to compare the effect of harmonic focus scalpel and electrosurgical knife in benign thyroid tumor surgery.A total of 317 patients who received thyroid surgery from july 2009 to march 2014 were included.Among these, 156 patients [31 males and 125 females; mean age of 50.4 ± 18.03 year (25-70)] received harmonic focus scalpel and 161 patients [33 males and 128 females; mean age of 51.2 ± 13.82 years (25-70)] received traditional electrosurgical knife.Reported complications include postoperative temporary hoarseness (n=8), permanent recurrent laryngeal nerve injury (n=?), thyroid fossa hemorrhage (n=2) requiring surgical exploration and ligation, and all layers of incision were sutured again, and temporary and permanent hypoparathyroidism (n=?).In conclusion, compared with electrotome, harmonic focus scalpel in benign thyroid tumor surgery can shorten surgical incision, significantly shorten surgical duration, reduce the number of midline nodes during thyroidectomy and reduce intraoperative blood loss.However, the postoperative drainage volume was more in harmonic focus scalpel group.There was no significant difference in the incidence rate of postoperative complications, extubation time and postoperative hospital stay between the two groups.

Manufacturer Narrative

(b)(4).Batch #: unk.This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot/batch number has not been provided.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.

• Brand Name: UNK_ULTRACISION HARMONIC FOCUS
• Type of Device: UNK_ULTRACISION HARMONIC FOCUS
• 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: 15401357
• MDR Text Key: 299670948
• Report Number: 3005075853-2022-05941
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_ULTRACISION HARMONIC FOCUS
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: GENERATOR
• Patient Outcome(s): Required Intervention