MAUDE Adverse Event Report: ETHICON ENDO-SURGERY, LLC. HS SYNERGY DISECTING HOOK; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SNGHK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Dehydration (1807); Dysphagia/ Odynophagia (1815); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Vomiting (2144); Speech Disorder (4415)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).Date sent: 7/14/2023.B3: publication year of 2022.D4: 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Does the author/surgeon believe that the ethicon device caused or contributed to the patient complications mentioned in the article? if yes, please explain.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: analysis of different techniques of tonsillectomy: an insight.Authors: ajaz ul haq, chetan bansal, apoorva kumar pandey, v.P.Singh.Citation: indian j otolaryngol head neck surg (december 2022); 74(suppl 3):s5717¿s5730.Https://doi.Org/10.1007/s12070-021-02948-4.The objective of this study is to compare three different surgical techniques of tonsillectomy namely the cold dissection snare technique (cdst), bipolar electro-dissection technique (bedt) and harmonic scalpel technique (hst) and to identify the method which is safe, with less operative time, which offers decreased intra-operative blood loss and with lowest post-operative morbidity and complications.This prospective and comparative study was conducted over a time duration of 1 year 6 months from january 2018 to july 2019 after the approval from ethical committee.It enrolled 150 patients of age 4 to 40 years with recurrent tonsillitis.In this study 62% were male and 38% were female.56.67% belong to urban dwelling area whereas 43.33% were from rural area.In cold dissection snare technique (cdst), tonsillectomy was done by palatoglossal incision using toothed waugh forceps.In bipolar electro-dissection technique (bedt), dissection and coagulation were done with the same bipolar forceps.In harmonic scalpel technique (hst), ultrasonic cut ¿n seal device which is a handheld device, is used which utilizes ultrasonic energy at the blade tip to cut and coagulate the vessels or tissues simultaneously at low temperature heat (50¿100 degrees celsius) using the harmonic scalpel system.Reported complications included intraoperative blood loss (n=?), post-operative bleeding (n=16), post operative pain (n=?), dehydration (n=6), vomiting (n=6), odynophagia (n=21), infection of tonsillar bed (n=22), and change of voice (n=11).In conclusion, harmonic scalpel technique (hst) is the latest technique as it is associated with quicker procedure, less intraoperative blood loss and less post-operative pain.Morbidity in terms of post-operative hemorrhage and other complications (vomiting, dehydration, halitosis, odynophagia, infection of tonsillar bed) were also minimal with hst.So, to conclude the experience with hst thus far has been positive, and will continue to use it for tonsillectomy.We recommend that any institution involved with significant number tonsillectomies consider using it, as well.

• Brand Name: HS SYNERGY DISECTING HOOK
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• 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: kate karberg ; 475 calle c; guaynabo ; * ; 3035526892
• MDR Report Key: 17327169
• MDR Text Key: 319275053
• Report Number: 3005075853-2023-04939
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 10705036002819
• UDI-Public: 10705036002819
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K012176
• 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: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SNGHK
• Device Catalogue Number: SNGHK
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other